Principal Biostatistician (Associate Director Level)

About the Role

This role is in Early Development Biometrics (EDB), a core function within Product Development Data Sciences (PDD) that provides strategic leadership and scientific rigor across early clinical development at Roche. We partner across Biostatistics, Analytical Data Science, and Data Management to enable data-driven decision-making from first-in-human through proof-of-concept studies.

As trusted partners in early development, we design efficient and innovative clinical trials, apply rigorous statistical methods, and implement high-quality programming and analytical solutions to accelerate timelines, de-risk development, and increase the probability of technical success. Our integrated teams operate with agility and scientific depth, supporting exploratory analyses, early regulatory engagements, and complex data-generation needs across therapeutic areas.

Early Development Biometrics is also home to the Statistical Methodology group, which enables the most impactful use of quantitative methodology across PDD through internal consultation, external collaboration, and continuous capability building; and Visual Analytics, which creates and maintains interactive dashboards that drive high-quality Medical Data Review (MDR) and safety signal detection, aligned with Risk-Based Quality Management (RBQM) principles and Critical-to-Quality (CtQ) endpoints.

Responsibilities

• Lead the statistical design of complex or high-priority early-phase studies, including adaptive, platform, and biomarker-enriched trials.
• Champion the use of 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 the statistical framework that supports phase transitions, internal governance reviews, and regulatory interactions.
• Solve complex statistical challenges in early development using deep expertise and novel approaches, such as integrating translational data, navigating sparse or emerging datasets, and balancing speed with scientific rigor.
• Interpret and drive the narrative around emerging data, translating early signals into clear, meaningful 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, ensuring clarity, integrity, and scientific robustness.
• Lead sub-streams and functional contributions within disease area strategy and the integration of novel data sources, such as omics, imaging, and real-world data.
• Maintain strong connectivity and collaboration with other core biometrics functions within PDD, including Biostatistics, Analytical Data Science, and Data Management, ensuring early-phase analysis strategies are executable.

Qualifications

• 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 in 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.
• Demonstrated independent thinking and decision-making based on sound principles.

Preferred Qualifications

• Extensive experience working in cross-functional, global early development teams, with demonstrated ability to collaborate effectively across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams.
• Effective communication skills, including the 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, with a strong emphasis on early-phase (Phase I/II) trials, including first-in-human, dose-finding, and proof-of-concept studies.
• Excellent communication and influencing skills, with a proven track record of shaping clinical strategy, informing go/no-go decisions, and aligning statistical strategy with program goals.
• Demonstrated scientific leadership and mentoring within a matrixed organizational structure, including guiding junior statisticians and cross-functional colleagues on the application of innovative design and analysis techniques.
• Strategic mindset, with the ability to assess risk, anticipate data needs, and contribute to portfolio-level decisions, including dose/regimen optimization and early investment prioritization.
• Familiarity with innovative methods (e.g., Bayesian adaptive design, MIDD, complex modeling), and a working knowledge of evolving regulatory expectations and scientific trends relevant to early development.

Pay

The expected salary range for this position based on the primary location of California is $153,300 - $284,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Benefits

This position qualifies for the benefits detailed at the provided link.