Associate Director, Biostatistics

Role Summary

Associate Director of Biostatistics to provide statistical expertise and operational support across a variety of clinical activities with a focus on supporting early-stage and late-stage clinical programs. Serve as lead study statistician, collaborating with cross-functional teams to support clinical development and data-driven decision-making. Contribute hands-on to key deliverables, manage CROs, and provide guidance to junior team members.

Responsibilities

• Contribute to the statistical design and analysis of early and late phase clinical studies.
• Apply advanced statistical methods and data visualization skills to clinical trial data summaries and interpretations such as integrated safety and efficacy analyses for regulatory submissions.
• Serve as the biostatistics representative on cross-functional teams, ensuring alignment of statistical approaches with study and program objectives.
• Provide input on study design, endpoint selection, and sample size planning.
• Draft statistical analysis plans (SAPs) and support interpretation of results.
• Ensure the quality and accuracy of statistical deliverables by independently generating the statistical deliverables and/or independently reviewing and validating the statistical deliverables generated by either CRO or internal statistical programming team.
• Manage CROs and mentor junior staff or contractors as appropriate.

Qualifications

• Ph.D. in Biostatistics with 6+ years of relevant industry experience, or Master‚Äôs with 8+ years.
• Significant experience serving as a study statistician on global Phase III clinical trials, ideally in immunology or immune-mediated diseases.
• Demonstrated track record of supporting regulatory submissions (NDA/BLA/MAA), including integrated safety/efficacy analyses.
• Hands-on experience working in a biotechnology or pharmaceutical company environment.
• Proven ability to manage CROs and statistical programming teams in a sponsor setting.
• Strong foundation in clinical trial design, statistical analysis, and regulatory guidelines.
• Proficiency in statistical programming (SAS and R).
• Experience in publication work and/or analysis of real-world data preferred.
• Demonstrated ability to manage multiple priorities and work cross-functionally.
• Experience with both early-stage and late-phase clinical trials.

Skills

• Strong analytical thinking and attention to detail.
• Excellent verbal and written communication skills.
• Ability to work independently in a fast-paced, regulated environment.
• Ability to manage deliverables with competing priorities and influence others effectively.
• Strong organizational skills, with the ability to manage workflows and activities to meet department timelines.
• Collaborative mindset and ability to influence without authority.

Education

• Ph.D. in Biostatistics or equivalent; or Master‚Äôs with substantial industry experience as described in qualifications.

Additional Requirements

• Location: South San Francisco, CA; onsite Tue‚ÄìThu. Remote candidates in Pacific Time Zone considered case-by-case.