Statistical Science Director Infectious Disease
Core
Lead statistical strategies and technical activities for product development, regulatory submissions, and health technology assessment in the pharmaceutical industry.
Role type
Senior IC statistical science director (clinical trials)
Builds
Statistical design, regulatory strategy, and value demonstration for emerging product profiles
Domain
Pharmaceuticals / Clinical Trials
Required skills
Clinical trial design, regulatory strategy, statistical methodology, team leadership, cross-study support, external representation, novel statistical approaches
Preferred skills
Vaccines & Immunotherapy experience, national recognition as a statistical expert, publications
Technologies
R, SAS, Python, SQL, Biostatistical software
Responsibilities
Lead statistical design and strategy for product development plans and regulatory submissions; ensure quality of study designs and documents; quantify benefit, risk, value, and uncertainty of product profiles; provide global leadership to internal and external staff; partner with CROs; represent the company externally at health authorities and conferences; mentor statistics staff; implement novel statistical approaches
Seniority
Senior, hands-on IC with leadership