Associate Principal Biostatistician Clinical Safety Statistics (CSS)

Job description

Job Description In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, transparent communication, and effective management of product risk profiles across our company Research Laboratories pre- and post-marketing development stages. Key responsibilities for the position: Provide statistical support and leadership for projects related to the evaluation of clinical safety data. Interact with cross-functional Risk Management Safety Teams (RMSTs) on planning and executing evaluations of safety data for clinical development programs. Serve as a statistical representative and core member on the RMST. Design, develop and evaluate processes, methods and tools for safety data evaluation. Primary activities for the...