Director, Data Management & Biostatistics
Location
Bridgewater, NJ
Job Type
Full-time
Category
other-general
Posted
June 13, 2026
Description:
The Director, Data Management & Biostatistics provides strategic and operational leadership for all data management, biostatistics, and statistical programming activities supporting the company's pharmaceutical development portfolio. This role ensures the highest standards of data integrity, statistical rigor, and regulatory compliance across all phases of clinical development (Phase I–IV), enabling informed decision-making and successful global regulatory submissions. The Director partners closely with Clinical Development, Medical Affairs, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality, and external partners to deliver high-quality, inspection-ready data and analyses in accordance with FDA, EMA, ICH, and GxP requirements.
Essential Functions:
+ Define and execute the biometrics strategy for clinical development programs in alignment with portfolio and regulatory objectives.
+ Provide scientific leadership on study ...
The Director, Data Management & Biostatistics provides strategic and operational leadership for all data management, biostatistics, and statistical programming activities supporting the company's pharmaceutical development portfolio. This role ensures the highest standards of data integrity, statistical rigor, and regulatory compliance across all phases of clinical development (Phase I–IV), enabling informed decision-making and successful global regulatory submissions. The Director partners closely with Clinical Development, Medical Affairs, Clinical Operations, Regulatory Affairs, Pharmacovigilance, Quality, and external partners to deliver high-quality, inspection-ready data and analyses in accordance with FDA, EMA, ICH, and GxP requirements.
Essential Functions:
+ Define and execute the biometrics strategy for clinical development programs in alignment with portfolio and regulatory objectives.
+ Provide scientific leadership on study ...