Our Company: All Ways Caring HomeCare Overview: The Registered Nurse is a licensed professional who provides direct and indirect care to clients in their home environment in accordance with the organization's policies and procedures. The nurse instructs, motivates, and assists clients in health maintenance and disease prevention to improve their ability to live independently at home. The nurse supervises, directs the efforts of the Caregiver when involved in the client's plan of care. Based on state regulations, nurses may perform administrative and/or field/clinical responsibilities. External Job Description: Provides skilled nursing care/treatment to clients per Physicians Orders and Plan of Care Accurately documents nursing actions of all care given, individual's health status, and communicate with family and physicians Documents the progress and outcomes for established goals and informs physician, case manager, and families of changes in client's medical condition and needs Provides skilled nursing treatments per physician's orders and within the nurse's scope of practice Administers medication and management as needed Provides health teaching of client and assisting client in learning appropriate self-care techniques and safety measures Conducts nursing assessment visit as needed Reports all incidents per operation procedure and regulatory standards Follows policies and procedures according to operation, state and regulatory standards Uses safe body mechanics to prevent personal injury to self or client Maintains confidentiality of patient related information and honor patient rights May be asked to cover after hours, weekends, and holiday on call to meet the needs of clients Completes Start of Care assessments in person, where applicable and in accordance with state regulations Completes supervisory visits based on compliance and regulations to include review of plan of care, caregiver competency assessment, and completion of required documentation. Complete daily, monthly, quarterly and annual nursing documents as/if required Observes, assesses, plans, implements and evaluates nursing support for well, chronic or acutely ill individuals in a community or home setting Works closely with Director or Nursing/Nurse Supervisor and/or Branch Manager in planning, implementing, and evaluating programs and services to address the health needs of persons served Attends and participates in staff meetings, in-services and other meetings as requested Ensures compliance with state/local/payer requirements and that documentation reflects the care provided and meets company, regulatory and payer standards Ensures the ordering, reviewing, monitoring, discontinuation and, if necessary, the disposal of medications as prescribed by the physician Ensures that there are policies in place that address medication administration, medication errors, medication storage/access and medication destruction, and that these policies are reviewed at least annually and revised as necessary Transcribes or ensures transcription of physician phone orders and other medically related reports Ensures that furnishings, equipment, and supplies are maintained within guidelines established to prevent the spread of disease Ensures that appointments for health related issues are scheduled, completed and that appropriate response to findings are implemented in a timely manner Communicates with Branch Manager, Customer Service Manager and/or Scheduler when clients are hospitalized Provides new employee training, annual re-certification training, and competency validation for health and safety related topics May provide case management as required by state regulations Other duties as assigned Qualifications: Degree in Nursing from an accredited school One of more years of nursing experience preferred Home Health Care experience preferred Experience in administering medications Current and unrestricted registration and license in the state of the operation CPR professional certification General knowledge of computers and the ability to learn industry specific software and documentation applications Excellent oral, written, and interpersonal communication skills with all levels of personnel, internal and external to the company Excellent organizational and time management skills with a keen attention to details Capable of working responsibly with highly confidential information Ability to work effectively independently or in a team environment Ability to develop critical thinking skills, research situations, solve complex problems and deal with a variety of issues Ability to learn and complete various educational and position specific goals Meet all pre-employment requirements per company and/or state regulations Basic clinical skills Professional appearance and demeanor About our Line of Business: All Ways Caring HomeCare delivers quality, compassionate and highly individualized care and support that helps people in need of assistance stay at home - all while maximizing their dignity, privacy and independence. Whether recovering from illness, injury or surgery, living with a chronic disability or dealing with the natural process of aging, services are tailored to meet the individual needs of people of all ages, physical conditions and cognitive abilities. All Ways Caring HomeCare services include personal care and homemaking programs, professional nursing, geriatric care management, Alzheimer's/dementia care, respite care and other programs. For more information, please visit . Follow us on Facebook and LinkedIn. Salary Range: USD $39.00 / Hour<img src="https://www.jobg8.com/Tracking.aspx?gGkd25F89rdAb6Y1RKFmkQy" width="0" height="0" />

**Registered Nurse**

Join our team at All Ways Caring HomeCare, where we deliver quality, compassionate, and highly individualized care and support that helps people in need of assistance stay at home while maximizing their dignity, privacy, and independence.

**Job Description**

- Provides skilled nursing care/treatment to clients per physicians' orders and plan of care
- Accurately documents nursing actions of all care given, individual's health status, and communicates with family and physicians
- Documents the progress and outcomes for established goals and informs physician, case manager, and families of changes in client's medical condition and needs
- Provides skilled nursing treatments per physician's orders and within the nurse's scope of practice
- Administers medication and management as needed
- Provides health teaching to clients and assists clients in learning appropriate self-care techniques and safety measures
- Conducts nursing assessment visits as needed
- Reports all incidents per operation procedure and regulatory standards
- Follows policies and procedures according to operation, state, and regulatory standards
- Uses safe body mechanics to prevent personal injury to self or client
- Maintains confidentiality of patient-related information and honors patient rights
- May be asked to cover after hours, weekends, and holidays on call to meet the needs of clients
- Completes start of care assessments in person, where applicable and in accordance with state regulations
- Completes supervisory visits based on compliance and regulations to include review of plan of care, caregiver competency assessment, and completion of required documentation
- Observes, assesses, plans, implements, and evaluates nursing support for well, chronic, or acutely ill individuals in a community or home setting
- Works closely with Director of Nursing/Nurse Supervisor and/or Branch Manager in planning, implementing, and evaluating programs and services to address the health needs of persons served
- Attends and participates in staff meetings, in-services, and other meetings as requested
- Ensures compliance with state/local/payer requirements and that documentation reflects the care provided and meets company, regulatory, and payer standards
- Ensures the ordering, reviewing, monitoring, discontinuation, and if necessary, the disposal of medications as prescribed by the physician
- Ensures that there are policies in place that address medication administration, medication errors, medication storage/access, and medication destruction, and that these policies are reviewed at least annually and revised as necessary
- Transcribes or ensures transcription of physician phone orders and other medically related reports
- Ensures that furnishings, equipment, and supplies are maintained within guidelines established to prevent the spread of disease
- Ensures that appointments for health-related issues are scheduled, completed, and that appropriate response to findings are implemented in a timely manner
- Communicates with Branch Manager, Customer Service Manager, and/or Scheduler when clients are hospitalized
- Provides new employee training, annual re-certification training, and competency validation for health and safety-related topics
- May provide case management as required by state regulations
- Other duties as assigned

**Requirements**

- Degree in Nursing from an accredited school
- One or more years of nursing experience preferred
- Home health care experience preferred
- Experience in administering medications
- Current and unrestricted registration and license in the state of operation
- CPR professional certification
- General knowledge of computers and the ability to learn industry-specific software and documentation applications
- Excellent oral, written, and interpersonal communication skills with all levels of personnel, internal and external to the company
- Excellent organizational and time management skills with a keen attention to detail
- Capable of working responsibly with highly confidential information
- Ability to work effectively independently or in a team environment
- Ability to develop critical thinking skills, research situations, solve complex problems, and deal with a variety of issues
- Ability to learn and complete various educational and position-specific goals
- Meet all pre-employment requirements per company and/or state regulations
- Basic clinical skills
- Professional appearance and demeanor

**Benefits**

- Salary range: USD $39.00 / hour



Registered Nurse

Board Certified Behavior Analyst (BCBA) - ABA Centers of Georgia Kennesaw, GA SIGN-ON BONUS UP TO $25K RELOCATION PACKAGE UP TO $15K We've Created the Ideal BCBA Work Culture Student-loan repayment program for existing loans (up to $24,000 total - $1,000 per month) Lower-than-average billable hours requirement (27 hours per week) Smaller-than-average caseloads (8-10 cases, 180 RBT hours per week) Flexibility in scheduling where and when you work Special, Full-Time BCBA Benefits 401(k) program with generous employer match up to 6% Performance bonuses (average $2,700 twice yearly) BCBA referral bonuses ($5,000) RBT referral bonuses ($500) Tuition reimbursement for ongoing education (up to $2,500 per semester) 21 paid days off (15 days of PTO, which increases with tenure, plus 6 holidays) Medical, dental, vision, long-term disability, and life insurance CEU reimbursement Mileage reimbursement Why We're the Best Place to Be a BCBA! Dedication to Better Outcomes - Smaller caseloads combined with our established clinical infrastructure mean you can focus on delivering high-quality care and lasting impact for children and families AI-Driven Efficiency - Streamline your workflow, reduce administrative tasks, and automate reporting, giving you more time to focus on your clients Unlimited Career Growth - Enjoy long-term opportunities to advance your career without the pressure of private equity investors Mentorship & Leadership Access - Collaborate with experienced BCBAs and leaders dedicated to your success and professional development Special Interest Groups - Connect with peers to deepen your expertise in areas like assessment, severe behavior, and school collaboration On-Demand Clinical Support - Access continuous training and resources through our ABA Academy of Excellence to stay at the top of your game Investment in Talent - We hire top talent and invest in developing our RBT teams, ensuring the best care for our clients and stability for our BCBAs Commitment to Improving Autism Care - We're serious about innovation and change, as evidenced by having our own diagnostic teams and sponsorship of the Autism Research Laboratory at Temple University Industry Recognition - Proudly named in Inc. Magazine's "Best in Business" for Health Services, making a lasting impact on our field and society Education/Experience and Other Requirements BCBA certification Valid driver's license, reliable form of transportation, and proof of auto insurance. Ability to maintain clean background/drug screenings and driving record What You'll Do Design, implement, and monitor skill-acquisition and behavior-reduction programs Oversee the implementation of behavior-analytic programs by RBTs and caregivers Conduct assessments related to the need for behavioral intervention (e.g., preference assessment, functional assessment, staff performance assessment, etc.) Be willing and able to supervise others seeking BCBA certification weekly Other typical BCBA activities ABA Centers of Georgia Culture ABA Centers of Georgia was founded because of the barriers and wait times one person experienced while trying to get help for two young family members with autism. Our team members know that their work, whether it's accounting or providing therapy, is really about helping families. That's what drives us. To accomplish that, we need the best people. And that's why we've made ABA Centers of Georgia a place you can call your career home. Recruiter ID: ABA Centers of Georgia participates in the U.S. Department of Homeland Security E-Verify program.<img src="https://www.jobg8.com/Tracking.aspx?XRA8emp%2bQ%2fNoCmysEoaFkQd" width="0" height="0" />

**Board Certified Behavior Analyst (BCBA)**

Join our team at ABA Centers of Georgia in Kennesaw, GA, where we've created the ideal BCBA work culture. 

**Job Description**

- Design, implement, and monitor skill-acquisition and behavior-reduction programs
- Oversee the implementation of behavior-analytic programs by RBTs and caregivers
- Conduct assessments related to the need for behavioral intervention (e.g., preference assessment, functional assessment, staff performance assessment, etc.)
- Be willing and able to supervise others seeking BCBA certification weekly
- Other typical BCBA activities

**Requirements**

- BCBA certification
- Valid driver's license, reliable form of transportation, and proof of auto insurance
- Ability to maintain clean background/drug screenings and driving record

**Benefits**

- Sign-on bonus up to $25K
- Relocation package up to $15K
- Student-loan repayment program for existing loans (up to $24,000 total - $1,000 per month)
- Lower-than-average billable hours requirement (27 hours per week)
- Smaller-than-average caseloads (8-10 cases, 180 RBT hours per week)
- Flexibility in scheduling where and when you work
- 401(k) program with generous employer match up to 6%
- Performance bonuses (average $2,700 twice yearly)
- BCBA referral bonuses ($5,000)
- RBT referral bonuses ($500)
- Tuition reimbursement for ongoing education (up to $2,500 per semester)
- 21 paid days off (15 days of PTO, which increases with tenure, plus 6 holidays)
- Medical, dental, vision, long-term disability, and life insurance
- CEU reimbursement
- Mileage reimbursement

**Community Overview**

ABA Centers of Georgia was founded to address the barriers and wait times experienced while seeking help for family members with autism. Our team members understand that their work is about helping families, which drives us to hire the best people and create a supportive career environment.

BCBA

Job Description Grady Health System offers many career paths for experienced professionals. Whether you have many years of experience or are in the early stages of your career, you can find a rewarding career at Grady! SUMMARY The Certified Surgical Technologist reports to the OR Clinical manager. The Certified Surgical Technologist is an integral part of the OR team and works under the supervision of the registered nurse and delegator authority of the surgeon to facilitate the safe and effective management of surgical procedures by possessing the expertise in the theory and application of sterile and aseptic technique. Handles the instruments, supplies, and equipment necessary during the surgical procedure. The Certified Surgical Technologist has an understanding of the procedure being performed and anticipates the needs of the surgeon while having the necessary knowledge and ability to ensure quality patient care during the operative procedure and is vigilant for maintenance of the sterile field. QUALIFICATIONS High School Diploma or GED Associate Degree of Applied Science, or Surgical Technology preferred. Less than one (1) year job related experience including clinical's taken in a surgical technology program. One (1) or more year job related experience preferred. Certification in Surgical Technology (CST). or obtained within 6 months of hire Basic Life Support (BLS). Equal Opportunity Employer-Minorities/Females/Veterans/Individuals with Disabilities/Sexual Orientation/Gender Identity.<img src="https://www.jobg8.com/Tracking.aspx?fZA0wZDqfU6q5aBRIOwAmAt" width="0" height="0" />

**Certified Surgical Technologist**

Grady Health System offers many career paths for experienced professionals. Whether you have many years of experience or are in the early stages of your career, you can find a rewarding career at Grady!

**Job Description**

- The Certified Surgical Technologist reports to the OR Clinical manager.
- The Certified Surgical Technologist is an integral part of the OR team and works under the supervision of the registered nurse and delegator authority of the surgeon to facilitate the safe and effective management of surgical procedures by possessing the expertise in the theory and application of sterile and aseptic technique.
- Handles the instruments, supplies, and equipment necessary during the surgical procedure.
- The Certified Surgical Technologist has an understanding of the procedure being performed and anticipates the needs of the surgeon while having the necessary knowledge and ability to ensure quality patient care during the operative procedure and is vigilant for maintenance of the sterile field.

**Requirements**

- High School Diploma or GED
- Associate Degree of Applied Science, or Surgical Technology preferred
- Less than one (1) year job-related experience including clinicals taken in a surgical technology program
- One (1) or more year job-related experience preferred
- Certification in Surgical Technology (CST) or obtained within 6 months of hire
- Basic Life Support (BLS)

**Equal Opportunity Employer**

Grady Health System is an Equal Opportunity Employer for Minorities, Females, Veterans, Individuals with Disabilities, Sexual Orientation, and Gender Identity.

Certified Surgical Technologist- Operating Room

Board Certified Behavior Analyst (BCBA) - ABA Centers of Georgia Atlanta, GA SIGN-ON BONUS UP TO $25K RELOCATION PACKAGE UP TO $15K We've Created the Ideal BCBA Work Culture Student-loan repayment program for existing loans (up to $24,000 total - $1,000 per month) Lower-than-average billable hours requirement (27 hours per week) Smaller-than-average caseloads (8-10 cases, 180 RBT hours per week) Flexibility in scheduling where and when you work Special, Full-Time BCBA Benefits 401(k) program with generous employer match up to 6% Performance bonuses (average $2,700 twice yearly) BCBA referral bonuses ($5,000) RBT referral bonuses ($500) Tuition reimbursement for ongoing education (up to $2,500 per semester) 21 paid days off (15 days of PTO, which increases with tenure, plus 6 holidays) Medical, dental, vision, long-term disability, and life insurance CEU reimbursement Mileage reimbursement Why We're the Best Place to Be a BCBA! Dedication to Better Outcomes - Smaller caseloads combined with our established clinical infrastructure mean you can focus on delivering high-quality care and lasting impact for children and families AI-Driven Efficiency - Streamline your workflow, reduce administrative tasks, and automate reporting, giving you more time to focus on your clients Unlimited Career Growth - Enjoy long-term opportunities to advance your career without the pressure of private equity investors Mentorship & Leadership Access - Collaborate with experienced BCBAs and leaders dedicated to your success and professional development Special Interest Groups - Connect with peers to deepen your expertise in areas like assessment, severe behavior, and school collaboration On-Demand Clinical Support - Access continuous training and resources through our ABA Academy of Excellence to stay at the top of your game Investment in Talent - We hire top talent and invest in developing our RBT teams, ensuring the best care for our clients and stability for our BCBAs Commitment to Improving Autism Care - We're serious about innovation and change, as evidenced by having our own diagnostic teams and sponsorship of the Autism Research Laboratory at Temple University Industry Recognition - Proudly named in Inc. Magazine's "Best in Business" for Health Services, making a lasting impact on our field and society Education/Experience and Other Requirements BCBA certification Valid driver's license, reliable form of transportation, and proof of auto insurance. Ability to maintain clean background/drug screenings and driving record What You'll Do Design, implement, and monitor skill-acquisition and behavior-reduction programs Oversee the implementation of behavior-analytic programs by RBTs and caregivers Conduct assessments related to the need for behavioral intervention (e.g., preference assessment, functional assessment, staff performance assessment, etc.) Be willing and able to supervise others seeking BCBA certification weekly Other typical BCBA activities ABA Centers of Georgia Culture ABA Centers of Georgia was founded because of the barriers and wait times one person experienced while trying to get help for two young family members with autism. Our team members know that their work, whether it's accounting or providing therapy, is really about helping families. That's what drives us. To accomplish that, we need the best people. And that's why we've made ABA Centers of Georgia a place you can call your career home. Recruiter ID: ABA Centers of Georgia participates in the U.S. Department of Homeland Security E-Verify program.<img src="https://www.jobg8.com/Tracking.aspx?yqFseUf7CkdMVah44Nslagz" width="0" height="0" />

**Board Certified Behavior Analyst (BCBA)**

Join our team at ABA Centers of Georgia in Atlanta, GA, where we've created the ideal BCBA work culture. 

**Job Description**

- Design, implement, and monitor skill-acquisition and behavior-reduction programs
- Oversee the implementation of behavior-analytic programs by RBTs and caregivers
- Conduct assessments related to the need for behavioral intervention (e.g., preference assessment, functional assessment, staff performance assessment, etc.)
- Be willing and able to supervise others seeking BCBA certification weekly
- Other typical BCBA activities

**Requirements**

- BCBA certification
- Valid driver's license, reliable form of transportation, and proof of auto insurance
- Ability to maintain clean background/drug screenings and driving record

**Benefits**

- Sign-on bonus up to $25K
- Relocation package up to $15K
- Student-loan repayment program for existing loans (up to $24,000 total - $1,000 per month)
- Lower-than-average billable hours requirement (27 hours per week)
- Smaller-than-average caseloads (8-10 cases, 180 RBT hours per week)
- Flexibility in scheduling where and when you work
- 401(k) program with generous employer match up to 6%
- Performance bonuses (average $2,700 twice yearly)
- BCBA referral bonuses ($5,000)
- RBT referral bonuses ($500)
- Tuition reimbursement for ongoing education (up to $2,500 per semester)
- 21 paid days off (15 days of PTO, which increases with tenure, plus 6 holidays)
- Medical, dental, vision, long-term disability, and life insurance
- CEU reimbursement
- Mileage reimbursement

**Community Overview**

ABA Centers of Georgia was founded because of the barriers and wait times one person experienced while trying to get help for two young family members with autism. Our team members know that their work, whether it's accounting or providing therapy, is really about helping families. That's what drives us. To accomplish that, we need the best people. And that's why we've made ABA Centers of Georgia a place you can call your career home.

Board Certified Behavior Analyst (BCBA) - ABA Centers of Georgia Atlanta, GA SIGN-ON BONUS UP TO $25K RELOCATION PACKAGE UP TO $15K We've Created the Ideal BCBA Work Culture Student-loan repayment program for existing loans (up to $24,000 total - $1,000 per month) Lower-than-average billable hours requirement (27 hours per week) Smaller-than-average caseloads (8-10 cases, 180 RBT hours per week) Flexibility in scheduling where and when you work Special, Full-Time BCBA Benefits 401(k) program with generous employer match up to 6% Performance bonuses (average $2,700 twice yearly) BCBA referral bonuses ($5,000) RBT referral bonuses ($500) Tuition reimbursement for ongoing education (up to $2,500 per semester) 21 paid days off (15 days of PTO, which increases with tenure, plus 6 holidays) Medical, dental, vision, long-term disability, and life insurance CEU reimbursement Mileage reimbursement Why We're the Best Place to Be a BCBA! Dedication to Better Outcomes - Smaller caseloads combined with our established clinical infrastructure mean you can focus on delivering high-quality care and lasting impact for children and families AI-Driven Efficiency - Streamline your workflow, reduce administrative tasks, and automate reporting, giving you more time to focus on your clients Unlimited Career Growth - Enjoy long-term opportunities to advance your career without the pressure of private equity investors Mentorship & Leadership Access - Collaborate with experienced BCBAs and leaders dedicated to your success and professional development Special Interest Groups - Connect with peers to deepen your expertise in areas like assessment, severe behavior, and school collaboration On-Demand Clinical Support - Access continuous training and resources through our ABA Academy of Excellence to stay at the top of your game Investment in Talent - We hire top talent and invest in developing our RBT teams, ensuring the best care for our clients and stability for our BCBAs Commitment to Improving Autism Care - We're serious about innovation and change, as evidenced by having our own diagnostic teams and sponsorship of the Autism Research Laboratory at Temple University Industry Recognition - Proudly named in Inc. Magazine's "Best in Business" for Health Services, making a lasting impact on our field and society Education/Experience and Other Requirements BCBA certification Valid driver's license, reliable form of transportation, and proof of auto insurance. Ability to maintain clean background/drug screenings and driving record What You'll Do Design, implement, and monitor skill-acquisition and behavior-reduction programs Oversee the implementation of behavior-analytic programs by RBTs and caregivers Conduct assessments related to the need for behavioral intervention (e.g., preference assessment, functional assessment, staff performance assessment, etc.) Be willing and able to supervise others seeking BCBA certification weekly Other typical BCBA activities ABA Centers of Georgia Culture ABA Centers of Georgia was founded because of the barriers and wait times one person experienced while trying to get help for two young family members with autism. Our team members know that their work, whether it's accounting or providing therapy, is really about helping families. That's what drives us. To accomplish that, we need the best people. And that's why we've made ABA Centers of Georgia a place you can call your career home. Recruiter ID: ABA Centers of Georgia participates in the U.S. Department of Homeland Security E-Verify program.<img src="https://www.jobg8.com/Tracking.aspx?18sjO48iuT12XXzVL8Wmnwa" width="0" height="0" />

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

When it comes to finding the perfect locums assignment, sometimes it's all about who you know. CompHealth has been around for a long time and have a vast network of connections to facilities across the nation. Let one of our recruiters leverage this network to help you get ahead of the curve and find the assignment that's just right for you.<ul><li>Willing to wait for license</li><li>BC or BE required</li><li>Weekdays, Weekends, Call, Weekend call</li><li>C-section, vacuum assisted vaginal deliveries, newborn circumcision, hysteroscopy</li><li>Credentialing needed</li><li>DEA needed</li><li>We negotiate better pay and deposit it weekly</li><li>We arrange complimentary housing and travel and comprehensive malpractice coverage</li><li>We simplify the credentialing and privileging process</li><li>Access to online portal for assignment details and time entry</li><li>Your specialized recruiter takes care of every detail</li></ul> CompHealth JOB-<img src="https://www.jobg8.com/Tracking.aspx?Xz0AqDDx1m4xSsZaxJnv5gb" width="0" height="0" />

**Locums Assignment**

When it comes to finding the perfect locums assignment, sometimes it's all about who you know. CompHealth has been around for a long time and has a vast network of connections to facilities across the nation. Let one of our recruiters leverage this network to help you get ahead of the curve and find the assignment that's just right for you.

**Job Description**

- Willing to wait for license
- BC or BE required
- Weekdays, weekends, call, weekend call
- C-section, vacuum assisted vaginal deliveries, newborn circumcision, hysteroscopy
- Credentialing needed
- DEA needed
- We negotiate better pay and deposit it weekly
- We arrange complimentary housing and travel and comprehensive malpractice coverage
- We simplify the credentialing and privileging process
- Access to online portal for assignment details and time entry
- Your specialized recruiter takes care of every detail

Obstetrics/Gynecologist Is Wanted for Locums Assistance in GA

Overview: Join us at Concentra and receive an additional $15K bonus Bonus Potential! Monthly and Quarterly Bonus Incentives! Are you looking for a physician practice with a family environment, but with the benefits and support a large organization can provide? Where daily patient care is backed by evidenced based medicine and career options are limitless, then look no further! At Concentra, our Medical Directors spend most of their time clinically treating patients; the remaining time is focused on quality improvements and building the center business with the Center Leadership Team. This role offers an opportunity for physicians to blend their love of patient care with their management skills, working for the leader in the workplace health industry. Concentra is recognized as the nation's leading occupational health care company and one of "America's Greatest Workplaces," as noted in Newsweek. Responsibilities: Responsibilities This clinic-based position provides direct patient care, leading by example, and creating an exceptional patient experience Provides leadership in healthcare management to ensure day-to-day execution of medical model collaborating with therapists and specialists to drive optimal clinical outcomes and case closure Manages clinicians, support staff, and complies with APC supervisory requirements Creates a professional and collaborative working environment Works with leaders to identify and implement changes to ensure continuous medical clinic improvement Maintains relationships with center clients and payers Works with medical clinic leadership team to manage clinical and support staffing levels Promotes, cultivates, and exemplifies Concentra values for all clinic colleagues Fosters an environment of collaboration, professionalism, patient/colleague safety, quality care, continuous improvement and reward and recognition Possesses financial awareness and provides input to clinic budget and key business metrics Why Choose Us With more than 40 years of experience, Concentra is dedicated to our mission to improve the health of America's workforce, one patient at a time. With a wide range of services and proactive approaches to care, Concentra colleagues provide exceptional service to employers and exceptional care to their employees. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. . Qualifications: Qualifications Active and unrestricted medical license Unrestricted DEA license and dispensing license for state of jurisdiction (required prior to start date) Must be eligible to participate in Medicare Board Certification or Eligibility in an ABMS or AOA recognized specialty preferred FMCSA NRCME certification preferred or willingness to obtain Additional Data: Benefits: Many of our clinics offer working hours M-F, 8 to 5, no nights, no weekends, no holidays, no call Compensation package: Competitive base salary with annual merit increase opportunity Monthly Medical Director Stipend Monthly RVU Bonus Incentive Quarterly Quality Care Bonus Incentive Generous Paid Time Off package for new colleagues include: 24 days of Paid Time Off (annually, with roll-over) 5 days of Paid CME Time (annually) 6 Paid Holidays Medical Malpractice Coverage Reimbursement for dues upon approval, for the renewal of applicable licensure, certifications, memberships, etc. 401(k) with Employer Match Tuition Reimbursement opportunity Medical/Vision/Prescription/Dental Plans Life/Disability Insurance: Colleague Referral Bonus Program Opportunity to teach residents and students Training provided in Occupational Medicine Supplemental health benefits (accident, critical illness, hospital indemnity insurance) Pre-tax spending accounts (health care and dependent care FSA) Concentra accredited CME courses Occupational Health University Leadership development programs Relocation assistance (when applicable) Commuter benefits Identity theft services Colleague discount program Unmatched opportunities for advancement locally and nationally This job requires access to confidential and critical information, requiring ongoing discretion and secure information management. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Concentra is an Equal Opportunity Employer, including disability/veteran<img src="https://www.jobg8.com/Tracking.aspx?xX%2fzfyba5ACNpNi46%2bK9dwr" width="0" height="0" />

**Medical Director**

Join us at Concentra and receive an additional $15K bonus. Are you looking for a physician practice with a family environment, but with the benefits and support a large organization can provide? Where daily patient care is backed by evidence-based medicine and career options are limitless, then look no further! At Concentra, our Medical Directors spend most of their time clinically treating patients; the remaining time is focused on quality improvements and building the center business with the Center Leadership Team. This role offers an opportunity for physicians to blend their love of patient care with their management skills, working for the leader in the workplace health industry. Concentra is recognized as the nation's leading occupational health care company and one of "America's Greatest Workplaces," as noted in Newsweek.

**Job Description**

- This clinic-based position provides direct patient care, leading by example, and creating an exceptional patient experience.
- Provides leadership in healthcare management to ensure day-to-day execution of medical model collaborating with therapists and specialists to drive optimal clinical outcomes and case closure.
- Manages clinicians, support staff, and complies with APC supervisory requirements.
- Creates a professional and collaborative working environment.
- Works with leaders to identify and implement changes to ensure continuous medical clinic improvement.
- Maintains relationships with center clients and payers.
- Works with medical clinic leadership team to manage clinical and support staffing levels.
- Promotes, cultivates, and exemplifies Concentra values for all clinic colleagues.
- Fosters an environment of collaboration, professionalism, patient/colleague safety, quality care, continuous improvement, and reward and recognition.
- Possesses financial awareness and provides input to clinic budget and key business metrics.

**Requirements**

- Active and unrestricted medical license.
- Unrestricted DEA license and dispensing license for state of jurisdiction (required prior to start date).
- Must be eligible to participate in Medicare.
- Board Certification or Eligibility in an ABMS or AOA recognized specialty preferred.
- FMCSA NRCME certification preferred or willingness to obtain.

**Benefits**

- Many of our clinics offer working hours M-F, 8 to 5, no nights, no weekends, no holidays, no call.
- Competitive base salary with annual merit increase opportunity.
- Monthly Medical Director Stipend.
- Monthly RVU Bonus Incentive.
- Quarterly Quality Care Bonus Incentive.
- Generous Paid Time Off package for new colleagues includes:
  - 24 days of Paid Time Off (annually, with roll-over).
  - 5 days of Paid CME Time (annually).
  - 6 Paid Holidays.
- Medical Malpractice Coverage.
- Reimbursement for dues upon approval, for the renewal of applicable licensure, certifications, memberships, etc.
- 401(k) with Employer Match.
- Tuition Reimbursement opportunity.
- Medical/Vision/Prescription/Dental Plans.
- Life/Disability Insurance.
- Colleague Referral Bonus Program.
- Opportunity to teach residents and students.
- Training provided in Occupational Medicine.
- Supplemental health benefits (accident, critical illness, hospital indemnity insurance).
- Pre-tax spending accounts (health care and dependent care FSA).
- Concentra accredited CME courses.
- Occupational Health University.
- Leadership development programs.
- Relocation assistance (when applicable).
- Commuter benefits.
- Identity theft services.
- Colleague discount program.
- Unmatched opportunities for advancement locally and nationally.

Physician Clinic Medical Director

Overview: Licensed Physical Therapist Assistant (PTA) - Care Coordination Program Physical Therapy + Care Coordination: The Best of Both Worlds! We're looking for Physical Therapy Assistants to support our innovative new care coordination program! This opportunity empowers you to practice at the top of your license, while giving you the chance to branch out into care coordination duties designed to standardize your hours and grow your career. All this plus truly flexible scheduling, amazing benefits, and the ability to make a huge difference in the lives of seniors! Incentive Opportunities For some leadership positions at EmpowerMe Wellness, we offer financial incentive opportunities tied to performance. Be sure to ask your recruiter to learn more! Responsibilities: The Opportunity We are hiring a licensed Physical Therapist Assistant (PTA) to join our team and work with the residents of a senior living community that offers one or more of the following care settings: independent living, assisted living, and memory care. Therapy services for the residents at this community are covered by private insurance and/or Medicare Part B. As a PTA, you will be responsible for: Providing physical therapy and wellness services for older adults under the supervision of a PT as part of a multidisciplinary team Support care coordination efforts by conducting regular wellness checkpoint visits with patients, communicating with patients' providers and caregivers, and assisting patients with attending telehealth visits Maintaining professional practices and ethical standards in accordance with company-wide policies and clinical initiatives Contributing to program development, quality improvement, and problem-solving Assist with optimizing each patient's functional well-being and satisfaction Your Schedule While our clinics typically operate 8 a.m. to 5 p.m. Monday through Friday, our flexible scheduling lets you craft a schedule that's suited to your unique lifestyle! Our Amazing Benefits All Employees Get: Fun at Work, a Team You'll Love, and a Culture You Can Stand Behind! 401(k) Eligibility with Opportunity for Matching Funds Amazing Career Advancement and Cross Training Opportunities Recognition Programs Employee Assistance Program Part-Time Employees Also Get: Voluntary Benefits (Accident, Critical Illness, Hospital Indemnity, Identity Theft, Pet Protection) Full-Time Employees Also Get: Full Benefits, including HSA, FSA, and Life & Disability Insurance Voluntary Benefits (Accident, Critical Illness, Hospital Indemnity, Identity Theft, Pet Protection) Flexible Paid Time Off You're Our Perfect Fit If You're energetic, dedicated, and hard-wired to help others - especially seniors. You want to make a difference in the world and help others lead fuller, healthier lives. You want more than just a job you seek a calling - a mission you can feel great about. And you want a support system to ensure your career ascends to the highest of heights. Plus, you have the following: Completion of an accredited Physical Therapy Assistant program (New Grads Welcome) ️ Current PTA state licensure Excellent verbal and written communication skills A results-oriented mindset with a dash of critical thinking Tech-savvy skills - quick learners are our favorite kind! Professional curiosity and a knack for finding solutions Come be a part of our mission to make a positive impact on the lives of seniors. Apply today! Qualifications: About EmpowerMe Wellness EmpowerMe Wellness is on a mission to improve the lives of seniors and the communities they call home! We provide fully integrated healthcare to senior living communities nationwide, offering on-site care coordination, therapy, and pharmacy services. Our experienced team of more than 3,500 clinicians and professionals provide personalized health and wellness solutions that lead to healthier, happier tomorrows! To learn more about us, visit today. This employer is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, the employer will provide reasonable accommodations to qualified individuals with disabilities and encourages prospective employees and incumbents to discuss potential accommodations with the employer.<img src="https://www.jobg8.com/Tracking.aspx?C0GW9s3P3XfR6XHsq9w3rgs" width="0" height="0" />

**Licensed Physical Therapist Assistant (PTA) - Care Coordination Program**

Physical therapy and care coordination: the best of both worlds! We're looking for Physical Therapy Assistants to support our innovative new care coordination program. This opportunity empowers you to practice at the top of your license while giving you the chance to branch out into care coordination duties designed to standardize your hours and grow your career. All this plus truly flexible scheduling, amazing benefits, and the ability to make a huge difference in the lives of seniors!

**Job Description**

- Provide physical therapy and wellness services for older adults under the supervision of a PT as part of a multidisciplinary team
- Support care coordination efforts by conducting regular wellness checkpoint visits with patients, communicating with patients' providers and caregivers, and assisting patients with attending telehealth visits
- Maintain professional practices and ethical standards in accordance with company-wide policies and clinical initiatives
- Contribute to program development, quality improvement, and problem-solving
- Assist with optimizing each patient's functional well-being and satisfaction

**Your Schedule**

While our clinics typically operate 8 a.m. to 5 p.m. Monday through Friday, our flexible scheduling lets you craft a schedule that's suited to your unique lifestyle!

**Benefits**

All Employees Get:

- Fun at work, a team you'll love, and a culture you can stand behind
- 401(k) eligibility with opportunity for matching funds
- Amazing career advancement and cross-training opportunities
- Recognition programs
- Employee assistance program

Part-Time Employees Also Get:

- Voluntary benefits (Accident, Critical Illness, Hospital Indemnity, Identity Theft, Pet Protection)

Full-Time Employees Also Get:

- Full benefits, including HSA, FSA, and Life & Disability Insurance
- Voluntary benefits (Accident, Critical Illness, Hospital Indemnity, Identity Theft, Pet Protection)
- Flexible paid time off

**Requirements**

- Completion of an accredited Physical Therapy Assistant program (New Grads Welcome)
- Current PTA state licensure
- Excellent verbal and written communication skills
- A results-oriented mindset with a dash of critical thinking
- Tech-savvy skills - quick learners are our favorite kind!
- Professional curiosity and a knack for finding solutions

**Community Overview**

EmpowerMe Wellness is on a mission to improve the lives of seniors and the communities they call home! We provide fully integrated healthcare to senior living communities nationwide, offering on-site care coordination, therapy, and pharmacy services. Our experienced team of more than 3,500 clinicians and professionals provide personalized health and wellness solutions that lead to healthier, happier tomorrows!

Licensed Physical Therapist Assistant PTA - Care Coordination

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.

Healthcare Jobs in Hiram, Georgia