Principal Biostatistician (Associate Director Level)

Roche • South San Francisco, CA

4d • $153,300 - $284,700

About The Position

The Early Development Principal Statistician is a critical partner in the design and analysis of exploratory clinical studies. The role applies statistical expertise to guide early-phase trial strategy, design, and interpretation, ensuring scientific rigor while allowing flexibility for hypothesis generation and signal detection. The position contributes to protocol design, develops statistical analysis plans, and analyzes complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. It helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with evolving development strategy.

The role is part of Early Development Biometrics (EDB), a core function within Product Development Data Sciences at Roche. EDB provides strategic leadership and scientific rigor across early clinical development, partnering across Biostatistics, Analytical Data Science, and Data Management to support data-driven decisions from first-in-human through proof-of-concept studies. The function also includes Statistical Methodology and Visual Analytics groups.

The position leads statistical design for complex or high-priority early-phase studies, including adaptive, platform, and biomarker-enriched trials; champions innovative methodologies; ensures quality and strategic alignment across statistical deliverables; and contributes statistical content to major early regulatory submissions. It collaborates across functions and helps integrate novel data sources into disease-area strategy.

Requirements

• PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field.
• At least 6 years of experience in clinical trial statistics, including responsibility for study-level strategy and decision-making.
• Proven ability to lead statistical input into clinical development plans and regulatory submissions.
• Strong expertise applying advanced statistical methods to enable data-driven decision-making.
• Proficiency in SAS and/or R and deep familiarity with CDISC standards and evolving regulatory data requirements.
• Independent thinking and decision-making based on sound principles.

Nice To Haves

• Extensive experience in cross-functional, global early-development teams and effective collaboration across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.
• Ability to translate complex or exploratory statistical methodologies into actionable insights for clinical, regulatory, and non-technical audiences.
• Experience across multiple phases of drug development, particularly early-phase (Phase I/II) trials, including first-in-human, dose-finding, and proof-of-concept studies.
• Strong communication and influencing skills, with a track record of shaping clinical strategy, informing go/no-go decisions, and aligning statistical strategy with program goals.
• Scientific leadership and mentoring in a matrixed organization, including guiding junior statisticians and cross-functional colleagues on innovative design and analysis techniques.
• Strategic mindset, including assessing risk, anticipating data needs, and contributing to portfolio-level decisions such as dose/regimen optimization and early investment prioritization.
• Familiarity with innovative methods such as Bayesian adaptive design, MIDD, and complex modeling, and working knowledge of evolving regulatory expectations and scientific trends relevant to early development.

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, aligned with exploratory objectives and scientific hypotheses.
• Ensure strategic alignment and quality across statistical deliverables within early-phase programs, shaping frameworks that support phase transitions, internal governance reviews, and regulatory interactions.
• Resolve complex early-development statistical challenges, including integrating translational data, working with sparse or emerging datasets, and balancing speed with scientific rigor.
• Interpret emerging data and drive the narrative, translating 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 substreams and functional contributions within disease-area strategy and the integration of novel data sources, such as omics, imaging, and real-world data.
• Collaborate with Biostatistics, Analytical Data Science, and Data Management to ensure early-phase analysis strategies are executable.
• Contribute to protocol design, develop statistical analysis plans, and analyze complex data to inform early go/no-go decisions and regulatory interactions.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits detailed at the link provided in the posting; specific benefits are not listed.

What This Job Offers

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