Associate Director, Biostatistics

Role Summary

The Associate Director, Biostatistics is responsible for statistical activities in support of Medical Affairs activities, including contributing to scientific and methodological expertise to support medical strategy, publications, and external engagements. This role focuses on the design, execution, interpretation, and communication of analyses that inform medical decision-making, health outcomes, and scientific exchange. The successful candidate will interact with internal and external cross-functional study teams, support engagements with the medical community, and manage CRO biostatisticians and statisticians in preparing analysis files and performing statistical analyses.

Responsibilities

• Provide statistical input to medical publications, scientific congresses, and external collaborations
• Apply appropriate statistical methodologies supporting medical insights, value demonstration, safety monitoring, and lifecycle management
• Ensure high-quality statistical deliverables that meet scientific and regulatory standards
• Partner with colleagues in Medical Affairs, HEOR, Clinical Development, and other cross-functional teams to align statistical activities
• Translate statistical concepts into clear insights for medical and scientific stakeholders
• Stay current with evolving statistical methods, data sources, and regulatory expectations related to real-world evidence
• CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines to guide the CRO biostatistician and statistical programmers

Qualifications

• PhD or Master’s degree in Biostatistics, Statistics, or related field
• 7+ years (PhD) or 10+ years (Master’s) of biostatistics experience in the pharmaceutical/biotech industry
• Strong knowledge of statistical methodologies, current drug development trends, and regulatory environments
• Strong analytical and problem-solving skills; able to identify and investigate issues and causes independently and formulate potential solutions
• Excellent written and verbal communication skills, with the ability to engage both technical and non-technical audiences
• Excellent programming skills in SAS and/or R
• Ability to work as part of a cross-functional team in a fast-paced environment and to work collaboratively with external partners and vendors
• Experience contributing to medical publications and scientific communications preferred
• Familiarity with HEOR and real-world evidence analysis preferred

Skills

• Biostatistics methodology
• Statistical programming (SAS, R)
• Scientific communication and publication support
• Cross-functional collaboration
• Vendor and CRO management

Education

• PhD or Master’s degree in Biostatistics, Statistics, or related field

Additional Requirements

• Location: This is a U.S.-based remote role with quarterly or as-needed visits to the San Francisco, CA office