Principal Statistician
Core
Lead statistical strategy and design for late-stage (Phase 2/3) clinical trials and regulatory submissions in pharmaceutical development.
Role type
Principal Statistician (Clinical Development)
Builds
Pivotal clinical trial deliverables and regulatory submissions for new drug approvals
Domain
Pharmaceutical / Biostatistics / Clinical Trials
Required skills
Statistical inference, experimental design, clinical trial methodology, ICH guidelines, CDISC standards, SAS, R, regulatory strategy, adaptive methodologies
Preferred skills
MSc or PhD in Statistics/Biostatistics, experience overseeing CRO statisticians, track record of FDA/EMA drug approvals
Technologies
SAS, R
Responsibilities
Design clinical studies and guide statistical strategy; serve as primary statistical authority for pivotal trials; respond to health authority queries; partner with clinical teams on evidence-based decisions; lead integrated analyses and meta-analyses; contribute to publications and internal best practices.
Seniority
Principal, strategic advisor & hands-on IC