Associate Director/Director, Biostatistics

Calico • South San Francisco, CA

4h • $235,000 - $300,000 • Onsite

About The Position

The Associate Director or Director of Biostatistics provides statistical data analysis expertise and leadership for assigned clinical programs. The role works in a scientifically stimulating, collaborative environment with colleagues across basic research, computational biology, pharmacology, PKPD, and biomarker disciplines. The successful candidate will direct project teams toward effective strategies for integrating data across multiple platforms to derive meaningful inferences about the human condition.

Requirements

• Ph.D. in Biostatistics/Statistics or equivalent with at least 8 years of relevant work experience, or an M.S. in Biostatistics/Statistics with at least 10 years of relevant experience.
• Broad and thorough understanding of statistical principles and clinical trial methodology, with the ability to practice and implement them.
• Ability to develop innovative and creative statistical or 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.
• Willingness to work onsite at least four days a week.

Nice To Haves

• Experience supporting rare disease or other indications with small patient populations and limited clinical data.
• Experience with external control groups, natural history studies, patient registries, or systematic literature reviews.

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 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.
• Manage CROs, external statistical consultants, and statistical programming vendors.

Benefits

• Eligible for two annual cash bonuses.

What This Job Offers

• Job Type: Full-time
• Career Level: Director