Statistical Science Director V&I
Core
Lead statistical strategy 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 strategies, study designs, regulatory documents, and value/uncertainty analyses for emerging product profiles
Domain
Pharmaceutical industry + Clinical Statistics
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical trial leadership, regulatory strategy, statistical design, benefit/risk/uncertainty quantification, team mentorship, external representation, novel statistical methodology
Preferred skills
Vaccines & Immunotherapy experience, simulation programming, business development/in-licensing, SAS/R/Python proficiency, project management
Technologies
SAS, R, Python
Responsibilities
Lead statistical design and strategy for product development and regulatory plans; Ensure quality of study designs and regulatory submissions; Quantify benefit, risk, value, and uncertainty of product profiles; Provide global leadership and direct work for internal and external staff; Partner with CROs to ensure delivery quality and timelines; Represent the company externally with health authorities and at conferences; Mentor and coach statistics staff on technical education and training
Seniority
Senior, hands-on IC with strategic leadership