Principal Scientist, Biostatistics, Late-Stage Clinical Development

Role: Lead biostatistician in Late Development Statistics within BARDS, overseeing statistical support and leadership for drug/vaccine clinical projects. Responsibilities: design and analyze clinical trials, develop protocols and analysis plans, direct statistical teams, ensure regulatory compliance, and contribute to regulatory submissions. Engage with cross-functional teams including Clinical, Regulatory, Data Management, and external partners like CROs. Requirements: PhD or equivalent in statistics/biostatistics with 6+ years (PhD) or 9+ years (Master's) of relevant experience; expertise in statistical methodologies, experimental design, and software such as SAS or R; broad knowledge of worldwide regulatory standards and clinical trial phases II–V. Preferred: peer-reviewed publications, familiarity with biology and drug development processes, and experience in oncology or related therapeutic areas. HighValue: emphasis on clinical trial design, statistical analysis, regulatory interactions, and leadership in late-stage (Phases II–V) drug/vaccine development. WorkSetup: hybrid flexible location with 10% travel.