Senior Scientist, Stat. Programming, Late-Stage Development (Hybrid)
Core
Statistical programming for late-stage clinical development of drugs and vaccines, ensuring data integrity for regulatory submissions and safety/efficacy analysis.
Role type
Senior Scientist, Statistical Programming
Builds
Statistical analysis datasets, tables, listings, figures, and regulatory submission deliverables for global clinical trials.
Domain
Biopharmaceuticals / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming (data steps, procedures, macros, graph), CDISC standards, ADaM standards, clinical trial programming, statistical database design, project planning
Preferred skills
R programming, regulatory submission experience, team leadership, process improvement
Technologies
SAS, Microsoft Project
Responsibilities
Design and maintain statistical datasets for clinical trials; develop and validate analysis/reporting deliverables; coordinate global programming teams including outsource providers; lead project plans and resource forecasting; ensure compliance with global standards and SOPs.
Seniority
Senior, hands-on IC with project leadership
