Statistical Science Director Infectious Disease
Core
Lead statistical strategy and technical activities for infectious disease product development, regulatory submissions, and health technology assessments.
Role type
Senior IC statistical science director (infectious disease)
Builds
Statistical strategies for product development plans, regulatory submissions, and commercial presentations
Domain
Pharmaceutical industry, Infectious Disease
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery
Required skills
Clinical trial leadership, regulatory strategy design, statistical methodology expertise, team mentorship, cross-functional partnership, external representation, novel statistical approach implementation
Preferred skills
Vaccines & Immunotherapy experience, simulation programming for sample size/interim analyses, 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 activities; Ensure quality of study designs and regulatory submissions; Quantify benefit, risk, value, and uncertainty of product profiles; Provide global leadership to internal and external staff; Partner with CROs for delivery; Represent company externally with health authorities and advisory boards; Mentor and coach statistics staff; Implement novel statistical approaches
Seniority
Senior, hands-on IC with leadership