Senior Principal Statistician, Early Development (Director Level)
Core
Lead statistical design and strategy for complex early-phase clinical studies (first-in-class, seamless Phase I/II) to guide go/no-go decisions and regulatory interactions.
Role type
Senior Principal Statistician (Director Level, Strategy & Technical Leadership)
Builds
Early clinical trial designs, statistical analysis plans, regulatory submission components, and strategic portfolio decisions.
Domain
Biopharmaceuticals / Early Clinical Development / Biostatistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Advanced statistical design (Bayesian adaptive trials, model-based decision-making), early-phase clinical trial strategy, high-dimensional data analysis, regulatory engagement (FDA/EMA), cross-functional leadership, strategic agility
Preferred skills
Disease area statistical strategy leadership, AI/ML in early-phase analytics, real-world data integration, external scientific collaboration
Technologies
Bayesian adaptive trials, model-based decision-making, multimodal data integration (biomarkers, imaging, real-world data)
Responsibilities
Lead statistical design for complex early phase studies; serve as primary statistical advisor for therapeutic area strategy; anticipate methodological challenges in exploratory research; represent the function in senior governance for dose/regimen optimization; co-lead cross-functional initiatives to standardize adaptive designs; guide statistical content for regulatory engagements; provide technical leadership to statisticians.
Seniority
Director Level, Senior Principal (Strategy & Mentorship)
