Director, Biostatistics

Contact: View email address on click.appcast.io Location: South San Francisco, CA Work Arrangement: Onsite 4 Days a Week The Associate Director or Director of Biostatistics will be responsible for providing statistical data analysis expertise and leadership to support assigned clinical programs. They provide a scientifically stimulating and collaborative working environment, and this role will interact with scientists from a range of disciplines including basic research, computational biology, pharmacology, PKPD and biomarker experts. We are seeking a creative and innovative statistical scientist to direct project teams towards efficient strategies for data integration across multiple platforms with the ultimate goal of deriving meaningful inferences about the human condition.

Key Responsibilities:

• Independently lead biostatistical support for assigned therapeutic programs and clinical studies across development phases
• Develop statistical strategies aligned with clinical development objectives and regulatory requirements
• Collaborate with clinical and scientific teams to evaluate study design alternatives, assess risks and uncertainties, and support data-driven development decisions
• Provide statistical input into clinical development plans, study protocols, endpoint selection, sample size considerations, and overall evidence-generation strategies
• Develop and evaluate innovative trial designs, including adaptive designs, Bayesian approaches, and simulation-based methods, as appropriate
• Provide statistical expertise for studies involving small sample sizes, heterogeneous patient populations, rare diseases, and limited clinical data
• Communicate statistical concepts, assumptions, limitations, and implications clearly to cross-functional teams

Position Requirements:

• Ph.D. in Biostatistics/Statistics or equivalent with at least 8+ years’ relevant work experiences or M.S. in Biostatistics/Statistics with at least 10+ years’ relevant experience
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Leadership skills in priority evaluation, adapting to changes, conflict resolution, and effective partnership
• Ability to work independently, exercise sound scientific judgment, and manage multiple competing priorities
• Experience managing CROs, external statistical consultants, and statistical programming vendors
• Experience with NDA or other major regulatory submissions
• Excellent written and verbal communication skills, including the ability to communicate statistical concepts to non-statistical stakeholders
• Experience supporting rare disease or other indications with small patient populations and limited clinical data is preferred
• Experience with external control groups, natural history studies, patient registries, or systematic literature reviews is preferred
• Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $235,000 - $300,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.