Principal Biostatistician (Associate Director Level)

About the role

Early Development Biometrics (EDB) within Product Development Data Sciences at Roche is looking for a Principal Biostatistician (Associate Director level) in South San Francisco. The role leads the statistical design and analysis of exploratory early-phase clinical studies, partnering with Biostatistics, Analytical Data Science and Data Management to support first-in-human through proof-of-concept studies.

Key responsibilities

• Lead the statistical design of complex or high-priority early-phase studies, including adaptive, platform and biomarker-enriched trials
• Champion innovative methodologies such as Bayesian designs and model-based dose selection
• Ensure quality and strategic alignment of statistical deliverables across early-phase programs, supporting phase transitions, internal reviews and regulatory interactions
• Solve complex statistical challenges, such as integrating translational data and handling sparse or emerging datasets
• Interpret emerging data and turn early signals into clear insights for internal stakeholders and external communications
• Own the statistical content of major early regulatory submissions, such as INDs, EMA scientific advice packages and pre-IND or end-of-Phase 1 meetings
• Lead sub-streams and integrate novel data sources such as omics, imaging and real-world data
• Collaborate with Biostatistics, Analytical Data Science and Data Management to make early-phase analysis strategies executable

Required profile

• PhD or MSc in Statistics, Biostatistics or a closely related quantitative field
• At least 6 years of experience in clinical trial statistics, including study-level strategy and decision making
• Proven ability to lead statistical input into clinical development plans and regulatory submissions
• Independent thinking and sound decision-making
• Preferred: extensive experience in cross-functional global early-development teams, experience across multiple phases of drug development with a focus on Phase I/II, and a track record of mentoring junior statisticians

Required skills

• Proficiency in SAS and/or R
• Familiarity with CDISC standards and evolving regulatory data requirements
• Preferred: working knowledge of Bayesian adaptive design, MIDD and complex modeling

What we offer

• Expected salary range of $153,300 - $284,700 for the California location, depending on experience and qualifications
• A discretionary annual bonus may be available
• The position qualifies for the benefits described in the original listing
• No relocation benefits available