Statistical Science Director
Core
Lead statistical strategy and design for global medicine development, guiding programs from early discovery through registration to influence patient outcomes and business value.
Role type
Senior IC statistical science director (pharma/biostatistics)
Builds
Clinical development plans, study protocols, analysis plans, regulatory submissions, and benefit-risk assessments for novel therapies.
Domain
Pharmaceutical industry, clinical trial design, regulatory affairs, health technology assessment
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Statistical design and strategy, regulatory interaction and submissions, clinical trial protocol development, data-driven analysis, decision making in drug development, sophisticated statistical computation and methodology, team leadership and mentorship, external partnership management, project leadership, methodological innovation (adaptive/Bayesian designs)
Preferred skills
PhD in Statistics/Biostatistics, experience across multiple therapy areas, expertise in advanced trial designs (adaptive, Bayesian, platform/master protocols), proficiency in R and/or SAS, reproducible analysis practices, version control, scalable computing, influencing internal governance bodies
Technologies
R, SAS, version control systems, scalable computing environments
Responsibilities
Lead statistical design and strategy across product development plans; own statistical content for study designs, protocols, and analysis plans; quantify benefit, risk, and uncertainty of emerging product profiles; provide leadership and direction to internal and external statisticians; partner with CROs and represent the company with health authorities; maintain deep knowledge of statistical methodology and implement novel approaches; represent statistical strategy at internal governance review boards.
Seniority
Director, strategic leadership and team mentorship
