Director, Biostatistics, Late Clinical Stage

Role: Lead statistician for late-stage oncology clinical programs, serving as SME in biostatistics and providing strategic statistical support throughout product development. Responsibilities: guide study design, analysis plans, and regulatory submissions; collaborate with cross-functional teams (clinical operations, data management, programming); oversee DMC preparations; support global health authority interactions; and contribute to clinical publications. Qualifications: Ph.D. or M.S. in Statistics/Biostatistics with 8+ (Ph.D.) or 12+ (M.S.) years of biotech/pharma industry experience; extensive hands-on experience in late-stage oncology trial design and analysis; proficiency in SAS/R; strong knowledge of ICH/regulatory standards; excellent communication and project management skills. Preferred: involvement in NDA/BLA filings. HighValue: oncology, late-stage clinical development, RAS pathway, biologics or targeted therapies, regulatory interactions, global trial oversight. WorkSetup: on-site in Redwood City, CA, with a salary range of $211,000-$264,000, plus benefits, equity, and development opportunities.