Senior Statistical Scientist
Core
Lead statistical analyses, study design, and regulatory submissions for clinical studies in the pharmaceutical industry, ensuring compliance with SOPs and guidelines.
Role type
Senior IC statistical scientist (clinical development)
Builds
Clinical Development Plans, Statistical Analysis Plans, regulatory submission documents (eCTD, IB, PSUR, RMP), and study-level deliverables
Domain
Pharmaceutical industry + clinical trial statistics
Required skills
Clinical and pharmaceutical drug development knowledge, theoretical and applied statistics, SAS programming, regulatory environment understanding, study design and analysis, leadership and coaching
Preferred skills
R or other statistical software, CDISC (SDTM, ADaM), regulatory submission and defense, clinical program design, collaboration with CROs
Technologies
SAS, R
Responsibilities
Develop Statistical Analysis Plans and study-level deliverables, provide statistical input to protocols and CRFs, ensure scientifically justified result interpretation, provide programming support for reporting and simulations, contribute to CSRs and regulatory responses, coach less experienced statisticians, stay informed of new statistical methodologies and regulations
Seniority
Senior, hands-on IC with leadership responsibilities