Senior Scientist Statistical Programming, Late-Stage (Hybrid)
Core
Lead statistical programming for late-stage drug and vaccine clinical development, creating analysis datasets, tables, listings, and figures for regulatory submissions and post-marketing support.
Role type
Senior IC statistical programmer (late-stage clinical)
Builds
Statistical analysis datasets, tables, listings, figures, and regulatory submission deliverables for global clinical trials.
Domain
Biopharmaceuticals / Clinical Trials / Regulatory Affairs
Required skills
SAS programming (data steps, procedures, macros, graph), CDISC ADaM standards, clinical trial programming, statistical database design, project planning, global team coordination
Preferred skills
GenAI tools (R Shiny, Python), regulatory submission experience, mentoring programmers, process improvement, Microsoft Project
Technologies
SAS, R, Python, Microsoft Project
Responsibilities
Design and maintain statistical datasets for clinical development; develop and validate analysis/reporting deliverables; coordinate global programming teams including outsource providers; manage project plans and resource forecasting; serve as statistical programming point of contact.
Seniority
Senior, hands-on IC with leadership responsibilities
