Associate Principal Scientist, Statistical Programming
Core
Lead statistical programming for late-stage drug and vaccine clinical development, managing complex analysis datasets and regulatory submissions from individual trials to global applications.
Role type
Senior IC statistical programming lead (clinical trials)
Builds
Safety and efficacy analysis datasets, tables, listings, figures, and electronic regulatory submission deliverables
Domain
Life Sciences / Clinical Development / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS programming (data steps, procedures, macros, graph), CDISC and ADaM standards, clinical data management concepts, statistical modeling and terminology, regulatory submission experience, project planning and resource forecasting, team coordination
Preferred skills
None stated
Technologies
SAS, CDISC, ADaM
Responsibilities
Design and maintain statistical datasets for clinical development and safety evaluation; execute statistical analysis and report deliverables; coordinate global programming team activities including outsourced providers; ensure compliance with global standards and departmental SOPs; manage project plans and resource forecasting; serve as the statistical programming point of contact throughout the project lifecycle
Seniority
Senior, hands-on IC with leadership responsibilities