Senior Principal Statistician, Early Development

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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  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 Methods Collaboration & Outreach (MCO), 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 Early Development 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…