Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director, Clinical Trial Diversity - Epidemiology - Global Oncology Clinical Development Functional Excellence team. role is crucial to advancing our commitment to diversity in clinical trials, supporting efforts to develop inclusive, data-driven solutions. The successful candidate will manage and analyze global epidemiological data and to ensure that diverse patient populations are represented in our trials. The incumbent would also be responsible for consulting with Global Clinical Leads on DS Diversity Action Plans regarding epidemiology data. This role reporting to the Clinical Trial Diversity Head, GOCD Functional Excellence, would also be responsible for collaborating with Global Clinical Lead (GCL) and Global Clinical Operations Director, Trial Feasibility, Recruitment and Retention based on diversity metrics developed by GOCD. Responsibilities: Epidemiology in Clinical Trial Diversity:<ul><li>Lead the development, implementation, and management of a data infrastructure and strategy specifically focused on diversity in epidemiology to support clinical trial initiatives.</li><li>Collaborate with cross-functional teams to integrate diverse epidemiological datasets into a centralized analytics framework for inclusion into the DS Diversity Action Plans and the site feasibility strategy.</li><li>Maintain data integrity and compliance with regulatory standards while overseeing data acquisition and processing.</li><li>Data Analytics and Insights Generation:</li><li>Develop robust analytical models to identify trends, gaps, and opportunities for diverse population representation across clinical trials.</li><li>Perform detailed statistical analysis and present insights to drive data-informed decisions, improve trial diversity, and meet both regulatory and internal diversity goals.</li><li>Generate reports, dashboards, and presentations for senior management and key stakeholders, summarizing key findings, metrics, and data trends.</li></ul> Cross-functional Collaboration and Influence:<ul><li>Creates a central repository for diversity related data analysis</li><li>Partner closely with internal stakeholders, including Clinical Safety and Pharmacovigilance epidemiology, biostatistics, clinical operations, regulatory, and external partners, to ensure alignment on diversity data needs and objectives.</li><li>Serve as a subject matter expert in diversity-related data analysis and epidemiology, contributing to cross-functional strategic discussions and decisions.</li></ul> Innovation and Continuous Improvement:<ul><li>Proactively identify areas for improvement in data collection and analysis methods to enhance diversity insights and outcomes.</li><li>Stay updated on industry trends, regulatory changes, and technological advancements in diversity data management and epidemiology to ensure best practices.</li><li>Additional non-Project related activities: Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical trial diversity activities, and innovations in addition to amending best practices, as appropriate and in alignment with stakeholders. Specific project assignments may include support in creating and deploying training materials for study teams regarding populating Diversity Action Plans. The Clinical Trial Diversity - Epidemiology role ensures positive / professional interactions and timely collaboration within and beyond Clinical Development with key stakeholders and supporting functions.</li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education: <ul><li>Bachelor's degree in science, engineering or business required and</li><li>Advanced degree in science or business preferred</li></ul> Experience:<ul><li>4 or More Years</li><li>5-10 years of relevant epidemiology and clinical data tools development, or consulting experience.</li><li>Prior work experience as in epidemiology, biostatistics, or similar role within pharmaceutical drug development desirable.</li><li>Prior experience in collaborating cross-functionally in an international company preferred required</li></ul> Travel:<ul><li>Ability to travel up to 10% Global travel might be required</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.<img src="https://www.jobg8.com/Tracking.aspx?yqFseUf7CkeDf8tdOsxuywz" width="0" height="0" />

**Associate Director, Clinical Trial Diversity - Epidemiology**

Join a legacy of innovation 125 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Summary**

The Associate Director, Clinical Trial Diversity - Epidemiology - Global Oncology Clinical Development Functional Excellence team role is crucial to advancing our commitment to diversity in clinical trials, supporting efforts to develop inclusive, data-driven solutions. The successful candidate will manage and analyze global epidemiological data and ensure that diverse patient populations are represented in our trials. The incumbent would also be responsible for consulting with Global Clinical Leads on DS Diversity Action Plans regarding epidemiology data. This role, reporting to the Clinical Trial Diversity Head, GOCD Functional Excellence, would also be responsible for collaborating with Global Clinical Lead (GCL) and Global Clinical Operations Director, Trial Feasibility, Recruitment and Retention based on diversity metrics developed by GOCD.

**Responsibilities**

**Epidemiology in Clinical Trial Diversity:**

- Lead the development, implementation, and management of a data infrastructure and strategy specifically focused on diversity in epidemiology to support clinical trial initiatives.
- Collaborate with cross-functional teams to integrate diverse epidemiological datasets into a centralized analytics framework for inclusion into the DS Diversity Action Plans and the site feasibility strategy.
- Maintain data integrity and compliance with regulatory standards while overseeing data acquisition and processing.

**Data Analytics and Insights Generation:**

- Develop robust analytical models to identify trends, gaps, and opportunities for diverse population representation across clinical trials.
- Perform detailed statistical analysis and present insights to drive data-informed decisions, improve trial diversity, and meet both regulatory and internal diversity goals.
- Generate reports, dashboards, and presentations for senior management and key stakeholders, summarizing key findings, metrics, and data trends.

**Cross-functional Collaboration and Influence:**

- Create a central repository for diversity-related data analysis.
- Partner closely with internal stakeholders, including Clinical Safety and Pharmacovigilance epidemiology, biostatistics, clinical operations, regulatory, and external partners, to ensure alignment on diversity data needs and objectives.
- Serve as a subject matter expert in diversity-related data analysis and epidemiology, contributing to cross-functional strategic discussions and decisions.

**Innovation and Continuous Improvement:**

- Proactively identify areas for improvement in data collection and analysis methods to enhance diversity insights and outcomes.
- Stay updated on industry trends, regulatory changes, and technological advancements in diversity data management and epidemiology to ensure best practices.
- Additional non-project related activities: Aid in identifying and raising opportunities for improvement initiatives, fit-for-use clinical trial diversity activities, and innovations in addition to amending best practices, as appropriate and in alignment with stakeholders. Specific project assignments may include support in creating and deploying training materials for study teams regarding populating Diversity Action Plans. The Clinical Trial Diversity - Epidemiology role ensures positive/professional interactions and timely collaboration within and beyond Clinical Development with key stakeholders and supporting functions.

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

**Education:**

- Bachelor's degree in science, engineering or business required
- Advanced degree in science or business preferred

**Experience:**

- 4 or more years
- 5-10 years of relevant epidemiology and clinical data tools development or consulting experience.
- Prior work experience in epidemiology, biostatistics, or similar role within pharmaceutical drug development desirable.
- Prior experience in collaborating cross-functionally in an international company preferred.

**Travel:**

- Ability to travel up to 10%. Global travel might be required.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Clinical Trial Diversity - Epidemiology

Kyo is a leading provider of Applied Behavior Analysis (ABA) therapy, dedicated to empowering children with autism and their families to achieve meaningful outcomes. Since 2005, we have partnered with thousands of families across 12 states, delivering effective, convenient, and child-centric ABA therapy designed around each child's unique strengths, needs and goals. At Kyo, our mission is rooted in a commitment to making every moment count for the children and families we support. As a Behavior Therapist (BT), you'll work 1-on-1 with clients in home, school, or community settings, using a play-based approach tailored to each child's unique interests. Join our team for robust mentorship, numerous opportunities for growth, and a flexible work environment-while making a meaningful impact every day! Pay Range: $25.00-$29.00 DOE WHY CHOOSE US? Career with purpose: Transform lives by helping children with autism achieve meaningful outcomes. Flexibility: Balance work and life on your own terms 1:1 Mentorship: Receive robust mentorship to grow & excel Paid ABA Training: Attend our Behavior Therapist Academy with paid coursework Company-Paid Credentials: We cover your RBT credentials or state licenses (i.e. RBAI, CBT) Professional Development: Acquire skills that open doors across healthcare and beyond Employee rewards: Enjoy referral bonuses, performance incentives, and more Mileage Reimbursement: Get paid for drive time between work appointments Employee Assistance Program: Access support and wellness resources whenever needed Comprehensive Benefits: Medical, vision, dental and life insurance benefits for staff working 30+ hours/week, plus 401k benefits for all Tuition Reimbursement & Supervision Hours: Get support for tuition (BCBA coursework and Purdue Global coursework) Inclusive Company Culture: We celebrate diverse perspectives as a driver of superior results WHAT YOU'LL NEED: Passion for Impact: Love for and experience working with children. Flexible Availability: Choose the schedule that suits your lifestyle, we've got options that fit your needs. A Part-time position requires minimum availability of either: 1) Three weekdays per week, from 3-7pm + two days from 8am-12pm or 11:30am-3pm OR 2) Five weekdays per week from 3-7pm (Monday-Friday). A Full-time position requires Monday-Friday 8am-7pm availability (maximum 8 hours worked per day). Educational Requirements: High School diploma or equivalent. Tech-Savviness: Comfortable with technology. Reliable Transportation: Own vehicle, valid license, car insurance. Please see all requirements listed in our full job description via the link provided. Job Types: Full-time, Part-time Pay: $25.00 - $29.00 per hour Benefits: 401(k) 401(k) matching Cell phone reimbursement Commuter assistance Dental insurance Employee assistance program Health insurance License reimbursement Mileage reimbursement Opportunities for advancement Paid orientation Paid sick time Paid time off Paid training Professional development assistance Referral program Safety equipment provided Travel reimbursement Tuition reimbursement Vision insurance Schedule: Monday to Friday Work Location: In person<img src="https://www.jobg8.com/Tracking.aspx?s9C9mpSRxCiZTtVaPqMAIQi" width="0" height="0" />

**Behavior Therapist**

Kyo is a leading provider of Applied Behavior Analysis (ABA) therapy, dedicated to empowering children with autism and their families to achieve meaningful outcomes. Since 2005, we have partnered with thousands of families across 12 states, delivering effective, convenient, and child-centric ABA therapy designed around each child's unique strengths, needs, and goals. At Kyo, our mission is rooted in a commitment to making every moment count for the children and families we support.

As a Behavior Therapist (BT), you'll work 1-on-1 with clients in home, school, or community settings, using a play-based approach tailored to each child's unique interests. Join our team for robust mentorship, numerous opportunities for growth, and a flexible work environment while making a meaningful impact every day!

**Job Description**

- Work 1-on-1 with clients in home, school, or community settings using a play-based approach.
- Participate in robust mentorship and numerous opportunities for growth.
- Make a meaningful impact every day.

**Requirements**

- Passion for impact: Love for and experience working with children.
- Flexible availability: Choose the schedule that suits your lifestyle. A part-time position requires minimum availability of either: 1) Three weekdays per week, from 3-7pm + two days from 8am-12pm or 11:30am-3pm OR 2) Five weekdays per week from 3-7pm (Monday-Friday). A full-time position requires Monday-Friday 8am-7pm availability (maximum 8 hours worked per day).
- Educational requirements: High school diploma or equivalent.
- Tech-savviness: Comfortable with technology.
- Reliable transportation: Own vehicle, valid license, car insurance.

**Benefits**

- Pay range: $25.00-$29.00 DOE.
- Career with purpose: Transform lives by helping children with autism achieve meaningful outcomes.
- Flexibility: Balance work and life on your own terms.
- 1:1 mentorship: Receive robust mentorship to grow and excel.
- Paid ABA training: Attend our Behavior Therapist Academy with paid coursework.
- Company-paid credentials: We cover your RBT credentials or state licenses (i.e., RBAI, CBT).
- Professional development: Acquire skills that open doors across healthcare and beyond.
- Employee rewards: Enjoy referral bonuses, performance incentives, and more.
- Mileage reimbursement: Get paid for drive time between work appointments.
- Employee assistance program: Access support and wellness resources whenever needed.
- Comprehensive benefits: Medical, vision, dental, and life insurance benefits for staff working 30+ hours/week, plus 401k benefits for all.
- Tuition reimbursement & supervision hours: Get support for tuition (BCBA coursework and Purdue Global coursework).
- Inclusive company culture: We celebrate diverse perspectives as a driver of superior results.

**Schedule**

- Monday to Friday.

**Work Location**

- In person.

Behavior Technician

Kyo is a leading provider of Applied Behavior Analysis (ABA) therapy, dedicated to empowering children with autism and their families to achieve meaningful outcomes. Since 2005, we have partnered with thousands of families across 12 states, delivering effective, convenient, and child-centric ABA therapy designed around each child's unique strengths, needs and goals. At Kyo, our mission is rooted in a commitment to making every moment count for the children and families we support. As a Behavior Therapist (BT), you'll work 1-on-1 with clients in home, school, or community settings, using a play-based approach tailored to each child's unique interests. Join our team for robust mentorship, numerous opportunities for growth, and a flexible work environment-while making a meaningful impact every day! Pay Range: $23.00-$27.00 DOE _ Afternoon availability is not required for part-time CBTs _ WHY CHOOSE US? Career with purpose: Transform lives by helping children with autism achieve meaningful outcomes. Flexibility: Balance work and life on your own terms 1:1 Mentorship: Receive robust mentorship to grow & excel Paid ABA Training: Attend our Behavior Therapist Academy with paid coursework Company-Paid Credentials: We cover your RBT credentials or state licenses (i.e. RBAI, CBT) Professional Development: Acquire skills that open doors across healthcare and beyond Employee rewards: Enjoy referral bonuses, performance incentives, and more Mileage Reimbursement: Get paid for drive time between work appointments Employee Assistance Program: Access support and wellness resources whenever needed Comprehensive Benefits: Medical, vision, dental and life insurance benefits for staff working 30+ hours/week, plus 401k benefits for all Tuition Reimbursement & Supervision Hours: Get support for tuition (BCBA coursework and Purdue Global coursework) Inclusive Company Culture: We celebrate diverse perspectives as a driver of superior results WHAT YOU'LL NEED: Passion for Impact: Love for and experience working with children. Flexible Availability: Choose the schedule that suits your lifestyle, we've got options that fit your needs. A Part-time position requires minimum availability of either: 1) Three weekdays per week, from 3-7pm + two days from 8am-12pm or 11:30am-3pm OR 2) Five weekdays per week from 3-7pm (Monday-Friday). A Full-time position requires Monday-Friday 8am-7pm availability (maximum 8 hours worked per day). Educational Requirements: High School diploma or equivalent. Tech-Savviness: Comfortable with technology. Reliable Transportation: Own vehicle, valid license, car insurance. Please see all requirements listed in our full job description via the link provided. Job Types: Full-time, Part-time Pay: $23.00 - $27.00 per hour Benefits: 401(k) 401(k) matching Dental insurance Employee assistance program Health insurance Paid time off Professional development assistance Referral program Tuition reimbursement Vision insurance Schedule: Monday to Friday Work Location: In person<img src="https://www.jobg8.com/Tracking.aspx?ez1k66e9tkfIw%2b0fPdOYGwu" width="0" height="0" />

**Behavior Therapist**

Kyo is a leading provider of Applied Behavior Analysis (ABA) therapy, dedicated to empowering children with autism and their families to achieve meaningful outcomes. Since 2005, we have partnered with thousands of families across 12 states, delivering effective, convenient, and child-centric ABA therapy designed around each child's unique strengths, needs, and goals. At Kyo, our mission is rooted in a commitment to making every moment count for the children and families we support.

As a Behavior Therapist (BT), you'll work 1-on-1 with clients in home, school, or community settings, using a play-based approach tailored to each child's unique interests. Join our team for robust mentorship, numerous opportunities for growth, and a flexible work environment while making a meaningful impact every day!

**Job Description**

- Work 1-on-1 with clients in home, school, or community settings
- Use a play-based approach tailored to each child's unique interests

**Requirements**

- Passion for impact: Love for and experience working with children
- Flexible availability: Choose the schedule that suits your lifestyle
- Educational requirements: High school diploma or equivalent
- Tech-savviness: Comfortable with technology
- Reliable transportation: Own vehicle, valid license, car insurance

**Benefits**

- Pay range: $23.00 - $27.00 per hour
- 401(k) and 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Paid time off
- Professional development assistance
- Referral program
- Tuition reimbursement
- Vision insurance

**Schedule**

- Monday to Friday

**Work Location**

- In person

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary This position provides support of secondary data studies in the study design, statistical analysis, interpretation of results with some supervision. This position interacts with study teams to provide statistical and scientific expertise in the project deliverables. This position is also expected to provide an excellent communication with people from the different functions. This position works under some supervision to solve study/analytics problems. Responsibilities - Secondary Data Study Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and study report: Supports statistical activities for studies including study design, protocol development, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and study report input and review. Acts as main statistical contact for the assigned studies and projects. Work effectively with the study team to support and provide the planned deliverables. - Real-World Evidence (RWE) Activities: Provides guidance in scientific and statistical aspects of RWE activities and support deliverables to ensure the quality. RWE activities include the real-world data (RWD) inquires, RWD/E consultation, and the feasibility assessment using the secondary data. Work closely with the business partner to support and provide the planned deliverables. - Excellent Communication: Work effectively with the customers/stakeholders and clearly communicate the statistical and scientific input in the design, conduct, analysis, and results interpretation. - RWE Analytics: Foster new methodology and provide innovative analytics technique method (e.g. External Control Arm, machine learning, predictive model). Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - PhD in Statistics or Biostatistics or pharmaco-epidemiology or other related field preferred - Master's Degree in Statistics/Biostatistics or pharmaco-epidemiology or other related field preferred Experience Qualifications - 4 or More Years relevant experience in the pharmaceutical industry with Ph.D preferred - 4 or More Years with Masters preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.<img src="https://www.jobg8.com/Tracking.aspx?kW%2bUkb41TFCaxlSc2bR8xAl" width="0" height="0" />

**Statistical Analyst**

Join a legacy of innovation 110 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- Provides support of secondary data studies in the study design, statistical analysis, interpretation of results with some supervision.
- Interacts with study teams to provide statistical and scientific expertise in the project deliverables.
- Works under some supervision to solve study/analytics problems.
- Supports statistical activities for studies including study design, protocol development, statistical analysis plan (SAP) development, analysis files development, statistical analysis accuracy validation, results interpretation, and study report input and review.
- Acts as main statistical contact for the assigned studies and projects.
- Works effectively with the study team to support and provide the planned deliverables.
- Provides guidance in scientific and statistical aspects of real-world evidence (RWE) activities and supports deliverables to ensure quality.
- Engages in RWE activities including real-world data (RWD) inquiries, RWD/E consultation, and feasibility assessment using secondary data.
- Works closely with business partners to support and provide planned deliverables.
- Communicates effectively with customers/stakeholders and clearly conveys statistical and scientific input in design, conduct, analysis, and results interpretation.
- Fosters new methodology and provides innovative analytics techniques (e.g., external control arm, machine learning, predictive model).

**Requirements**

- PhD in Statistics or Biostatistics or pharmaco-epidemiology or other related field preferred.
- Master's Degree in Statistics/Biostatistics or pharmaco-epidemiology or other related field preferred.
- 4 or more years relevant experience in the pharmaceutical industry with Ph.D. preferred.
- 4 or more years with Master's preferred.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Biostatistics, DI-COE- RWE Real World Evidence

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems. Responsibilities: Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): <ul><li>Leads statistical activities for very complex studies or an entire project. Act as statistical expert in the assigned projects.</li><li>Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and Regions the compound will be submitted, and helps to maximize the success of the drug product.</li><li>Serves as project statistician and ensures the study designs are scientifically sound, the efficacy and safety information meets regulatory requirements of the countries and Regions the drugs will be submitted.</li><li>Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis and result interpretation throughout the drug project; Leads the planning and analysis of integrated efficacy and safety data;</li><li>Review the relevant sections of the electronic common technical document (eCTD).</li></ul> Drug Development Strategy: <ul><li>Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted.</li><li>Research statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.</li></ul> CRO / Vendor Oversight: <ul><li>Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; Guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high quality deliverables.</li></ul> Global Health Authority Interaction / Negotiation: <ul><li>Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed.</li></ul> Global BDO Strategy to Improve Drug Development: <ul><li>Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.</li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Master's Degree in statistics or biostatistics required</li><li>PhD in statistics or biostatistics preferred</li></ul> Experience Qualifications: <ul><li>10+ Years of relevant experience in the pharmaceutical industry with a masters degree required.</li><li>7+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel.</li><li>Ability to travel up to 20% International travel required.</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. <img src="https://www.jobg8.com/Tracking.aspx?8vtR65FWeb%2bOqPaSTWzJ7gg" width="0" height="0" />

**Statistical Expert**

Join a legacy of innovation 110 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- Position leads very complex studies or entire drug project in study design, data analysis, and interpretation of results independently with minimal supervision.
- Provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision.
- Interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians.
- Works under minimal supervision to solve complex project problems.

**Responsibilities**

- **Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR):**
  - Leads statistical activities for very complex studies or an entire project. Acts as statistical expert in the assigned projects.
  - Guides the project team in using the most efficient or innovative study design by considering the regulatory agencies' requirements for the country and regions the compound will be submitted, and helps to maximize the success of the drug product.
  - Serves as project statistician and ensures the study designs are scientifically sound, and the efficacy and safety information meets regulatory requirements of the countries and regions the drugs will be submitted.
  - Ensures consistency in data collection, derived data definition, analysis file structure, statistical analysis, and result interpretation throughout the drug project; leads the planning and analysis of integrated efficacy and safety data.
  - Reviews the relevant sections of the electronic common technical document (eCTD).

- **Drug Development Strategy:**
  - Provides input to the entire development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, and efficacy and safety information to be collected meet regulatory agencies' requirements for countries and regions the drug is to be submitted.
  - Researches statistical methodologies and addresses specific statistical issues in the design of clinical studies from preclinical through Phase 3 and 4.

- **CRO / Vendor Oversight:**
  - Participates in drafting request for proposal for CRO selection. Reviews and negotiates baseline budget and timelines; guides CRO biostatistician and statistical programmers on assigned projects to ensure consistency in derived data definition, analysis files structure, analysis methodologies, and accuracy of analysis results. Ensures timely delivery of high-quality deliverables.

- **Global Health Authority Interaction / Negotiation:**
  - Authors documents and responses submitted to Health Authorities globally with some guidance from supervisor. Represents statistics function to Health Authorities meetings as needed.

- **Global BDO Strategy to Improve Drug Development:**
  - Leads global BDO initiatives to improve the harmonization and efficiency of drug development which leads to cost savings with minimal supervision.

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

- **Education Qualifications (from an accredited college or university):**
  - Master's Degree in statistics or biostatistics required.
  - PhD in statistics or biostatistics preferred.

- **Experience Qualifications:**
  - 10+ years of relevant experience in the pharmaceutical industry with a master's degree required.
  - 7+ years of relevant experience in the pharmaceutical industry with a PhD preferred.
  - Ability to travel up to 20%. International travel required.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Director, Biostatistics-RWE

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary The purpose of this job is to provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission. It will also improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs. Responsibilities - Supporting project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision. By guiding other internal programmer or by self, perform programmatic review of Study Date Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review, review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate stud level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement, review study submission data package and ensure its quality and integrity. - Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies. Responsibilities include: develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting - Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality. Responsibilities include: contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard, develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis - Develop and maintain necessary programming macros or tools to effectively support all programming needs. Responsibilities include: identify the macros or tools that will facilitate programing efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance - Evaluate, assess and enhance DSI computing environment system. Responsibilities include: continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system, develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Bachelor's Degree an accredited institution in a science or in a technical field preferred - Master's Degree preferred Experience Qualifications - 10 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Bachelor's degree preferred - 7 or More Years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Masters degree preferred - Previous experience supporting SAS macro and/or system utility development preferred - Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred - Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred - Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred - Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred - Solid background in applied statistics preferred - Solid knowledge of new advanced statistical methods using SAS and R preferred - Advanced knowledge in database structures and set-up preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.<img src="https://www.jobg8.com/Tracking.aspx?QXmTq%2bTLcYuob1gs5QHEcwx" width="0" height="0" />

**Statistical Programming Technical Support**

Join a legacy of innovation 125 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- Provide statistical programming technical support to DSI project teams on all statistical programming deliverables and programming submission.
- Improve Daiichi Sankyo programming efficiency by developing tools and macros and build up standard on SDTM/ADaM datasets, and TFLs.
- Support project lead on outsourced projects, act as statistical programming subject matter expert (SME) to support outsourced programming activities and be responsible for the programming technical decision.
- Perform programmatic review of Study Data Tabulation Model (SDTM) and analysis (including Analysis Data Model (ADaM) datasets as well as TLFs generated by statistical vendor, ensure correct and effective vendor programming implementation, and expedite the preparation of regulatory submissions.
- Make strategic programming decisions and planning, review Case Report Form (CRF) annotation and SDTM dataset, identify data inconsistencies and support data review.
- Review analysis dataset specifications and ensure correct interpretation of SAP, develop independent programs to validate study level analysis dataset and TLFs generated by vendor, ensure analysis dataset in compliance with CDISC and submission requirement.
- Review study submission data package and ensure its quality and integrity.
- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response to regulatory agencies.
- Develop programming submission strategy, perform integrated analysis of efficacy and safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting.
- Develop DSI programming standard template on datasets and TFLs to improve efficiency and quality.
- Contribute to CRF and SDTM standard development, develop, implement, and maintain SDTM, ADaM dataset and TLF standard.
- Develop sample programs to generate and validate SDTM, ADaM dataset and TLFs, support technical training and ensure effective implementation of SDTM, ADaM and TLFs standard in clinical trial data analysis.
- Develop and maintain necessary programming macros or tools to effectively support all programming needs.
- Identify the macros or tools that will facilitate programming efficiency, lead the macro or tool development by working with contractors or by self, and support the macro or tool implementation and maintenance.
- Evaluate, assess and enhance DSI computing environment system.
- Continue assessing DSI new computing environment system for programming and analysis efficiency, identify system bug/issue and lead the activity to enhance the system.
- Develop system training materials and work as the SME to support implementation, evaluate, request and approve system upgrades, and propose/develop system utilities.

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

**Education Qualifications**

- Bachelor's Degree from an accredited institution in a science or in a technical field preferred.
- Master's Degree preferred.

**Experience Qualifications**

- 10 or more years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Bachelor's degree preferred.
- 7 or more years proven experience within pharmaceutical industry, or CROs supporting statistical analysis of clinical trials programming with Master's degree preferred.
- Previous experience supporting SAS macro and/or system utility development preferred.
- Advanced working knowledge of all aspects of the SAS programming language used in clinical trials programming preferred.
- Advanced working knowledge of CDISC SDTM and ADaM, and extensive experiences of their implementation in clinical trials analysis preferred.
- Advanced understanding of statistical concepts in support of analyses and reporting of clinical trials preferred.
- Knowledge of all phases of drug development, including early and late phase clinical development and submission preferred.
- Solid background in applied statistics preferred.
- Solid knowledge of new advanced statistical methods using SAS and R preferred.
- Advanced knowledge in database structures and set-up preferred.

Associate Director, Evidence Generation Statistical Programming

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary:<ul><li>The position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.</li><li>The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.</li><li>The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.</li><li>The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables</li></ul> Responsibilities: Study Responsibility <ul><li>Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close out. Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan</li><li>Database specifications, Database build, interim data cuts, Database lock and study archiving</li><li>Leads the data review process in collaboration with the study team to ensure data quality</li><li>Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.</li><li>Must comply with international regulations</li><li>Ensure inspection readiness as well as prepare potential audits linked to assigned studies</li></ul> Vendor Oversight <ul><li>Under supervision, responsible for routine oversight of vendor delivery , to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.</li><li>Participates in drafting request for proposal for CRO selection. Reviews base-line budget and timelines. Contributes to budget management and activities across the project duration</li></ul> Operational Excellence <ul><li>Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions</li><li>Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy</li><li>Any other duties deemed pertinent to the needs of the business</li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Bachelor's Degree or an equivalent combination of education and experience preferred</li></ul> Experience Qualifications: <ul><li>At least 4 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting</li><li>Or</li><li>At least 7 or More Years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting, in lieu of Bachelor's Degree required</li><li>Experience in oncology Therapeutic Area and/or in late phase projects is an advantage</li><li>Good communication skills, both oral and written, in explaining in simple terms complex concepts</li><li>Solid understanding of Data Integrity and GDPR principles</li><li>Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.</li><li>Fundamental negotiation and project management skills</li><li>Ability and interest to work remotely with worldwide team members across cultures and time zones</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. <img src="https://www.jobg8.com/Tracking.aspx?XRA8emp%2bQ%2fOnCOQvgwpxqAd" width="0" height="0" />

**Data Management Specialist**

Join a legacy of innovation 110 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- The position holder will manage, with direction, end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
- The position holder will partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
- The position will have a working knowledge of Electronic Data Capture/related applications and industry standards, and moderate technical skills in working with data received from CROs and other third-party vendors.
- The position holder may act as a Biometrics Project Manager to plan and coordinate cross functional Evidence Generation execution of the study deliverables.

**Responsibilities**

**Study Responsibility**

- Responsible, with supervision, for study activities assigned related to the Data Management study set up, conduct, and close out. Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan.
- Database specifications, Database build, interim data cuts, Database lock and study archiving.
- Leads the data review process in collaboration with the study team to ensure data quality.
- Contribute, with supervision, to documents submitted to Regulatory or Pricing Authorities.
- Must comply with international regulations.
- Ensure inspection readiness as well as prepare potential audits linked to assigned studies.

**Vendor Oversight**

- Under supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.
- Participates in drafting request for proposal for CRO selection. Reviews base-line budget and timelines. Contributes to budget management and activities across the project duration.

**Operational Excellence**

- Participate in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
- Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy.
- Any other duties deemed pertinent to the needs of the business.

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

**Education Qualifications**

- Bachelor's Degree or an equivalent combination of education and experience preferred.

**Experience Qualifications**

- At least 4 or more years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting.
- Or at least 7 or more years of experience supporting drug development and/or post marketing in Clinical Research, Pharmaceutical, CRO or Medical Device setting, in lieu of Bachelor's Degree required.
- Experience in oncology Therapeutic Area and/or in late phase projects is an advantage.
- Good communication skills, both oral and written, in explaining in simple terms complex concepts.
- Solid understanding of Data Integrity and GDPR principles.
- Thorough knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
- Fundamental negotiation and project management skills.
- Ability and interest to work remotely with worldwide team members across cultures and time zones.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Manager, Evidence Generation Data Management

Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary: <ul><li>The position holder will support end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.</li><li>The position holder will support the study lead and partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.</li><li>The position will understand Electronic Data Capture/related applications and industry standards, and fundamental technical skills in working with data received from CROs and other third-party vendors.</li></ul> Responsibilities: Study Responsibilities: <ul><li>Responsible, with strict supervision, for study activities assigned related to the Data Management study set up, conduct, and close out.</li><li>Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, Database specifications, Database build, interim data cuts, Database lock and study archiving.</li><li>Must comply with international regulations, with guidance under Manager.</li><li>Ensure inspection readiness, as well as prepare potential audits linked to assigned studies</li></ul> Vendor Oversight: <ul><li>With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.</li></ul> Operational Excellence: <ul><li>Participate, with supervision, in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.</li><li>Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy.</li><li>Any other supporting duties deemed pertinent to the needs of the business (included but not limited to: town halls meetings coordination).</li></ul> Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university): <ul><li>Bachelor's Degree preferred or an equivalent combination of education and experience</li></ul> Experience Qualifications: <ul><li>At least 2 or More Years of experience supporting drug development and/or post marketing in clinical research, Pharmaceutical, CRO or Medical Device setting</li><li>Or</li><li>At least 4 or More Years of experience supporting drug development, post marketing in clinical research, Pharmaceutical, CRO or Medical Device, in lieu of a Bachelor's Degree required</li><li>Good communication skills, both oral and written, in explaining in simple terms complex concepts</li><li>Fundamental understanding of Data Integrity and GDPR principles</li><li>Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research</li><li>Ability and interest to work remotely with worldwide team members across cultures and time zones</li></ul> Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. <img src="https://www.jobg8.com/Tracking.aspx?Xz0AqDDx1m5xTOknXbZpEgb" width="0" height="0" />

**Data Management Specialist**

Join a legacy of innovation 110 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- The position holder will support end-to-end delivery of data management services for assigned studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget.
- The position holder will support the study lead and partner with internal and external stakeholders to optimize Data Management technology, processes, and standards.
- The position will understand Electronic Data Capture/related applications and industry standards, and fundamental technical skills in working with data received from CROs and other third-party vendors.

**Responsibilities**

**Study Responsibilities:**

- Responsible, with strict supervision, for study activities assigned related to the Data Management study set up, conduct, and close out.
- Ensure timely, to budget and accurate completion of Data Management deliverables, including but not exclusive to the Data Management Plan, Database specifications, Database build, interim data cuts, Database lock and study archiving.
- Must comply with international regulations, with guidance under Manager.
- Ensure inspection readiness, as well as prepare potential audits linked to assigned studies.

**Vendor Oversight:**

- With supervision, responsible for routine oversight of vendor delivery, to ensure compliance with the protocol, external/internal standards applicable regulatory guidelines, Policies, SOPs, and other relevant guidelines.

**Operational Excellence:**

- Participate, with supervision, in Global Evidence Generation initiatives to improve the harmonization and efficiency of processes and/or develop and implement innovative solutions.
- Maintains current knowledge of industry best practice in Data Management methodology, Data Integrity, and Data Privacy.
- Any other supporting duties deemed pertinent to the needs of the business (included but not limited to: town halls meetings coordination).

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

**Education Qualifications (from an accredited college or university):**

- Bachelor's Degree preferred or an equivalent combination of education and experience.

**Experience Qualifications:**

- At least 2 or more years of experience supporting drug development and/or post marketing in clinical research, Pharmaceutical, CRO or Medical Device setting.
- Or at least 4 or more years of experience supporting drug development, post marketing in clinical research, Pharmaceutical, CRO or Medical Device, in lieu of a Bachelor's Degree required.
- Good communication skills, both oral and written, in explaining in simple terms complex concepts.
- Fundamental understanding of Data Integrity and GDPR principles.
- Knowledge and understanding of the principles, concepts, methods, and standards of Clinical Research.
- Ability and interest to work remotely with worldwide team members across cultures and time zones.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Analyst, Evidence Generation Data Management

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position also guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses. Additionally, this position interacts with study teams, as well as statisticians and programmers at CROs. This position works under some supervision to solve complex study problems. Responsibilities - Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data. - Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile. - CRO / Vendor Oversight: Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines. - Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meeting or teleconferences with Health Authorities - Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company. QualificationsSuccessful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Master's Degree in statistics or biostatistics required - PhD in statistics or biostatistics preferred Experience Qualifications - 8+ Years of relevant experience in the pharmaceutical industry with a masters degree required - 5+ Years of relevant experience in the pharmaceutical industry with a PhD preferred Travel Ability to travel up to 10% Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.<img src="https://www.jobg8.com/Tracking.aspx?18sjO48iuT1VVwYYPw4%2fSQa" width="0" height="0" />

**Statistical Scientist**

Join a legacy of innovation 125 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- Position leads complex studies in study design, statistical analysis, and interpretation of results with some supervision.
- Contributes to specific aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision.
- Guides contract research organization (CRO) programmers and statisticians in preparing analysis files and performing statistical analyses.
- Interacts with study teams, as well as statisticians and programmers at CROs.
- Works under some supervision to solve complex study problems.

**Responsibilities**

- Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation, and CSR input and review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study team on all aspects of statistical activities; collaborates closely with data manager to ensure high-quality data.
- Drug Development Strategy: Provides input to multiple aspects of the development plan to ensure the study designs at each phase of the development are scientifically sound, can fulfill regulatory requirements, and deliver the pre-specified product profile.
- CRO / Vendor Oversight: Reviews CRO/vendor proposals and budgets. Establishes procedures through regular interaction, setting expectations on deliverables and timelines to guide CRO biostatisticians and statistical programmers on complex studies. Ensures deliverables are accurate and delivered according to the timelines.
- Global Health Authority Interaction / Negotiation: Contributes to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities.
- Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.

**Qualifications**

Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

**Education Qualifications**

- Master's Degree in statistics or biostatistics required
- PhD in statistics or biostatistics preferred

**Experience Qualifications**

- 8+ years of relevant experience in the pharmaceutical industry with a master's degree required
- 5+ years of relevant experience in the pharmaceutical industry with a PhD preferred

**Travel**

Ability to travel up to 10%.

Associate Director, Biostatistics - Oncology

Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThis position oversees and manages US Medical Affairs activities including strategy, communications, and medical affairs directed clinical activities across the oncology portfolio. The position has leadership responsibility for Medical Affairs personnel working on Oncology products that can range from late clinical phases through launch and post-approval. In partnership with the New Product or Commercial Brand Teams, the Medical Affairs lead develops the medical/commercial strategy based on the scientific development and appropriate communication for the products. The position must effectively collaborate with Clinical Research and with co-promote or co-development partners to effectively guide the scientific efforts needed in support of Daiichi Sankyo brands. Additionally, the Executive Director contributes to excellence in clinical research by developing strategies for lifecycle management, IIS programs and post approval clinical programs in consultation with commercial, development and outside experts, and by building the image of the company as a partner in research projects.Responsibilities - Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities, and investigator initiated studies, advocacy and sponsorships. Interact with investigators and members of the medical community to assist in understanding current academic, clinical trial and practice issues related to DS Oncology development and therapeutic strategies. - Partner with the commercial teams to oversee and assume responsibility for brand plans, including Medical objectives, strategies and tactics leading up to launch and carrying through to later stages of commercialization. - For Oncology portfolio serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development and co-promotion discussions. Foster bidirectional communication and alignment between US and Global Medical Affairs. - Oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the development of scientific content for medical communication and scientific education initiatives that occur as a result of studies conducted by the Oncology teams. - Attract and develop US Medical Affairs talent in oncology. Oversee the team, as well as, develop and effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the Medical Affairs Leadership Team and serve as the voice for oncology within the department. Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university) - Advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/scientific area required - MD strongly preferred - Board Certified/Eligible in Oncology or related specialty or equivalent clinical or research experience preferred - Bachelor's Degree preferably in scientific/medical field required Experience Qualifications - 10 or More Years overall related experience required - oncology, clinical, scientific experience and/or fluency required - Proven track record of excellent internal and external collaboration, with experience working successfully with cross-functional teams to achieve business results required - experience leading high performing teams with a focus on delivering results required - Experience with oncology medical strategies and clinical trial implementation required - 10 or More Years of experience in clinical / research / academic medicine or equivalent pharmaceutical industry experience preferred Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.<img src="https://www.jobg8.com/Tracking.aspx?%2fVhkNlMjLmAHrVZBbUSSnwe" width="0" height="0" />

**Oncology Medical Affairs Lead**

Join a legacy of innovation 125 years and counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

**Job Description**

- Serve as the face of Daiichi Sankyo US Medical Affairs to external stakeholders. Oversee a Medical Affairs oncology team that works alongside Oncology Field Medical Affairs for interactions with Key External Experts in Oncology including advisory boards, Congress activities, and investigator-initiated studies, advocacy, and sponsorships. Interact with investigators and members of the medical community to assist in understanding current academic, clinical trial, and practice issues related to DS Oncology development and therapeutic strategies.
- Partner with the commercial teams to oversee and assume responsibility for brand plans, including Medical objectives, strategies, and tactics leading up to launch and carrying through to later stages of commercialization.
- For the Oncology portfolio, serve as the US Medical Affairs lead or Global lead in development committees and global medical affairs activities. Represent Medical Affairs in new product planning, life cycle management, co-development, and co-promotion discussions. Foster bidirectional communication and alignment between US and Global Medical Affairs.
- Oversee the interpretation, publication/public disclosure, and interpretation of scientific data generated by studies conducted by the Oncology teams. Oversee the development of scientific content for medical communication and scientific education initiatives that occur as a result of studies conducted by the Oncology teams.
- Attract and develop US Medical Affairs talent in oncology. Oversee the team, as well as develop and effectively manage annual operating plan and budget for the Oncology Medical Strategy Group. Support the US Medical Affairs department through participation on the Medical Affairs Leadership Team and serve as the voice for oncology within the department.

**Requirements**

- Advanced doctorate degree (PharmD, PhD, MD, DO or equivalent) in medical/scientific area required
- MD strongly preferred
- Board Certified/Eligible in Oncology or related specialty or equivalent clinical or research experience preferred
- Bachelor's Degree preferably in scientific/medical field required
- 10 or more years overall related experience required
- Oncology, clinical, scientific experience and/or fluency required
- Proven track record of excellent internal and external collaboration, with experience working successfully with cross-functional teams to achieve business results required
- Experience leading high-performing teams with a focus on delivering results required
- Experience with oncology medical strategies and clinical trial implementation required
- 10 or more years of experience in clinical/research/academic medicine or equivalent pharmaceutical industry experience preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

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