Senior Director, Safety Biostatistics

Role: Senior Director of Safety Biostatistics at IDEAYA Biosciences, leading biostatistics for oncology drug development with a focus on safety and pharmacovigilance. Responsibilities: oversee biostatistics teams, develop clinical and safety analysis plans, author and review protocols, SAPs, and regulatory submissions (INDs, DSURs, CSRs); provide strategic input on study design and safety data interpretation; ensure high-quality statistical standards and collaborate across clinical, regulatory, and data teams; serve as a key stakeholder and represent the function externally. Requirements: Ph.D. or M.S. in Statistics or related field; 15+ years in drug development, including 10+ years in oncology and 8+ years supporting drug safety/pharmacovigilance; extensive experience with clinical trial design, regulatory submissions, and safety analysis; proven leadership in cross-functional teams; strong communication and organizational skills. HighValue: oncology, drug safety, pharmacovigilance, Phase 1-3 clinical trials, NDA/BLA submissions, statistical methodology expertise, regulatory interactions. WorkSetup: onsite in South San Francisco, CA, four days/week; some remote flexibility.