Genentech discovers, develops, manufactures and commercializes treatments for patients with serious and life-threatening medical conditions. Backed by North Carolina Biotechnology Center.
About the role
The Early Development Principal Statistician is a critical partner in the design and analysis of exploratory clinical studies, applying statistical expertise to guide early-phase trial strategy, design, and interpretation. This role ensures scientific rigor while maintaining the flexibility needed for hypothesis generation and signal detection.
What they're looking for
- ● You hold a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field
- ● You bring at least 6 years of experience in clinical trial statistics, including responsibility for study level strategy and decision making
- ● You have a proven ability to lead statistical input into clinical development plans and regulatory submissions
- ● You have strong expertise applying advanced statistical methods to enable data driven decision making
- ● You are proficient in SAS and or R and deeply familiar with CDISC standards and evolving regulatory data requirements
- ● You demonstrate independent thinking and make decisions based on sound principles
More about this 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. Together, we bring scientific rigor, technical innovation, and strategic insight to shape the future of early development and deliver better outcomes for patients.
Early Development Biometrics is also home to the Statistical Methodology group, which enables the most impactful use of quantitative methodology across PDD through internal...
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