Principal Biostatistician (Associate Director Level)

Genentech • Daly City, CA

1d • $153,300 - $284,700

About The Position

This role is part of Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) 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. Its integrated teams design efficient clinical trials, apply statistical methods, and deliver programming and analytical solutions for exploratory analyses, early regulatory engagements, and complex data-generation needs. The function also includes Statistical Methodology, which supports quantitative methodology across PDD, and Visual Analytics, which develops interactive dashboards for medical data review and safety signal detection.

The Early Development Principal Statistician is a critical partner in designing and analyzing exploratory clinical studies. The role applies statistical expertise to guide early-phase trial strategy, design, and interpretation, supporting scientific rigor while allowing flexibility for hypothesis generation and signal detection. The Statistician 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. The role helps shape the early clinical narrative by ensuring that data are robust, interpretable, and aligned with evolving development 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.
• Deep familiarity with CDISC standards and evolving regulatory data requirements.
• Ability to think independently and make decisions 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 explain complex or exploratory statistical methodologies as actionable insights for clinical, regulatory, and non-technical audiences.
• Experience across multiple phases of drug development, especially 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 experience in a matrixed organization.
• 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, as well as working knowledge of evolving regulatory expectations and scientific trends in early development.

Responsibilities

• Lead statistical design for 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 statistical frameworks that support phase transitions, internal governance reviews, and regulatory interactions.
• Solve complex early-development statistical challenges using deep expertise and novel approaches, 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, meaningful insights for internal stakeholders and external communications.
• Own the statistical content of major early regulatory submissions, including INDs, EMA scientific advice packages, and pre-IND or end-of-Phase-1 meeting materials.
• Lead substreams and functional contributions within disease-area strategy and integration of novel data sources, such as omics, imaging, and real-world data.
• Collaborate with core biometrics functions within PDD, including Biostatistics, Analytical Data Science, and Data Management, to ensure early-phase analysis strategies are executable.
• Contribute statistical input to clinical development plans and regulatory submissions.
• Guide and mentor junior statisticians and cross-functional colleagues on innovative design and analysis techniques.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• The position qualifies for company benefits detailed at the linked benefits information.

What This Job Offers

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