Daiichi Sankyo, Inc. Jobs

AI Summary

Lead statistical support for medium complexity studies, focusing on study design, protocol development, and statistical analysis. Collaborate closely with study teams, CROs, and internal programmers. Ensure high-quality data and accurate deliverables. Participate in global health authority interactions, contributing to drug development strategies.

AI Summary

This position supports secondary data studies by developing study protocols, statistical analysis plans, and interpreting results. It involves real-world evidence activities, fostering innovative analytics, and maintaining excellent communication with stakeholders to ensure quality deliverables.

AI Summary

The Senior Clinical Study Manager role involves leading the development and execution of clinical studies, ensuring adherence to Good Clinical Practices, SOPs, and FDA regulations. Responsibilities include managing study plans, overseeing CROs and vendors, monitoring trial performance, and ensuring budget compliance. This role requires strong communication, decision-making, and project management skills to ensure high-quality study deliverables and operational excellence.

AI Summary

This operational role supports project objectives by managing vendor interactions, packaging design, and patient kit supply, ensuring compliance with global regulatory standards. It requires expertise in GMPs, GCPs, and IRT systems with a focus on clinical supply management and drug dispensing control.

AI Summary

The Manager, Data Programmer supports Data Management and Biostatistics by performing programming tasks, including SAS programming and validation, managing external vendors, ensuring high-quality deliverables, and developing reports for clinical trials. The role involves creating and maintaining CDISC SDTM specifications, mentoring associates, and ensuring compliance with SOPs and industry standards, while contributing to innovation in reporting systems.

AI Summary

The Director of Clinical Development provides medical accountability and oversight for clinical trials, manages Phase 1-3 studies, and offers scientific expertise to colleagues. Responsibilities include medical monitoring, protocol development, and clinical data interpretation. This role involves collaboration with global teams, addressing regulatory questions, and leading clinical development strategies to advance innovative pharmaceutical therapies.

AI Summary

Support Global and Regional Quality Leads in delivering and executing R&D QA strategies and activities. Collaborate with stakeholders to ensure compliance, manage CAPAs, participate in audits, and drive continuous improvement in quality standards and processes.

AI Summary

The Project Manager (RACMC) leads complex filing activities, ensures compliance with regulatory standards, and manages resources efficiently. Responsibilities include coordinating global regulatory dossier submissions, managing risks, and implementing process improvements. The role requires collaboration with internal stakeholders, conducting regular project meetings, and maintaining IT tools and knowledge sites.

AI Summary

The intern will develop programming tools and create data visualization and summary tables using R/R Shiny. This role offers training in statistical programming within a pharmaceutical company and supports programming activities under supervision, contributing to department initiatives.

AI Summary

The intern will engage in statistical programming, focusing on developing programming tools like macros and apps. The role involves using SAS for data visualization and summary tables, supporting basic programming activities under supervision. Ideal candidates are detail-oriented, proficient in SAS, R/R Shiny, or Python, and possess strong communication skills.