Genentech · San Francisco
Otherposted 3w ago
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 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.
The Opportunity:
The Early Development Senior Prinicpal 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. Responsibilities include contributing to protocol design, developing statistical analysis plans, and analyzing complex, often high-dimensional data to inform early go/no-go decisions and regulatory interactions. The Statistician helps shape the early clinical narrative by ensuring data are robust, interpretable, and aligned with the evolving development strategy.
You lead the statistical design and strategy of the most complex early phase studies and programs (e.g., first-in-class, seamless Phase I/II trials, or novel platform designs), ensuring alignment with exploratory development goals and translational hypotheses
You serve as a primary statistical advisor for therapeutic area or disease area strategy, shaping portfolio decisions through innovative design and data interpretation approaches
You anticipate and address methodological challenges in exploratory clinical research, guiding the integration of multimodal data (e.g., biomarkers, imaging, real-world data) into early trial design and analysis
You represent the function in senior governance discussions, driving decisions on dose or regimen optimization, early investment, and progression to later stages
You co lead cross functional initiatives to improve early development statistical strategy and operational excellence, including standardization of adaptive design approaches and decision making frameworks
You guide the statistical content of strategic regulatory engagements (e.g., EMA Scientific Advice, FDA EoP1) and author key statistical components of submission packages
You provide technical leadership to statisticians and cross functional colleagues, acting as a recognized expert in early development design and a senior advisor across studies or therapeutic area teams
You actively contribute to internal innovation by proposing and evaluating new methods, supporting capability building, and aligning with enterprise level modeling and AI/ML efforts
Who You Are:
You hold a PhD or MSc in Statistics, Biostatistics, or a closely related quantitative field
You bring a minimum of 12 years of experience in clinical trial statistics, including advanced contributions to early development strategy
You have recognized expertise in applying advanced statistical design and modeling approaches (e.g., Bayesian adaptive trials, model-based decision-making) in early phase clinical development
You have a proven record of leadership in high impact cross functional projects or initiatives across multiple molecules or disease areas
You have outstanding communication skills with the ability to influence senior clinical and regulatory stakeholders
You demonstrate independent thinking and make decisions based on sound principles
You demonstrate excellent strategic agility including problem solving and critical thinking, with agility that extends beyond the technical domain
You demonstrate respect for cultural differences when interacting with colleagues in the global workplace
You have excellent verbal and written communication skills in presentation and writing, with the ability to explain complex technical concepts in clear language
Preferred:
Experience leading disease area statistical strategy or acting as a statistical representative in enterprise-level initiatives across Clinical Development, Clinical Pharmacology, Translational Medicine, Regulatory, and Biomarker teams
Experience leading disease area statistical strategy or acting as a statistical representative in enterprise-level initiatives
Familiarity with AI/ML, real-world data, or novel data sources in early-phase analytics
Contributions to external working groups, scientific collaborations, or published statistical innovation in early development
Relocation benefits are not available for this posting
The expected salary range for this position based on the primary location of California is $171,600 - $318,600. 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. This position also qualifies for the benefits detailed at the link provided below.
Benefits
#EDB
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