Associate Director, Biostatistics

Role: Associate Director, Biostatistics, providing strategic and operational leadership for clinical development programs in Virology, focusing on HIV, hepatitis, COVID-19, and cancer. Responsibilities include serving as lead statistician for Phase 1-3 trials, collaborating with cross-functional teams (Clinical Development, Safety, Pharmacology, Regulatory Affairs), and advising on study design, analysis plans, and regulatory documentation. The role encompasses overseeing statistical activities, contributing to scientific publications, and leading non-molecule projects when applicable. Qualifications require a Bachelor's degree with 10+ years, Master's with 8+ years, or PhD with 2+ years in biostatistics or related fields; expertise in drug development phases, regulatory standards (FDA/EMA, GCP), and statistical software is essential. Preferred skills include knowledge of innovative trial designs, experience in Virology, and leadership capabilities. The position emphasizes strategic thinking, collaboration, and adaptability within a GxP environment. Stakeholder engagement spans multiple teams, with a focus on high-quality statistical support across early to late-stage clinical trials. The work setup is not specified but involves cross-functional interactions, with a focus on clinical trial design, analysis, and regulatory input, primarily within the Biostatistics department.