Principal Statistical Programmer
Core
Provides project leadership and programming support for processing data from clinical studies, ensuring compliance with Statistical Analysis Plans and internal standards.
Role type
Principal Statistical Programmer
Builds
Analysis datasets, TFLs, standard tools, and submission requirements for clinical trials up to regulatory approval.
Domain
Clinical trials / Biopharmaceuticals
Deliverable
production ML models | product features | dashboards & analysis
Required skills
SAS (Base, Stat, Macro, graph), data model integration, validation plan development, program logic design, regulatory documentation, multidisciplinary team collaboration
Preferred skills
Department training development, process improvement, complex data presentation support
Technologies
SAS, Regeneron standard data models, internal standards and guidelines
Responsibilities
Lead programming and QC of analysis datasets; integrate data across studies; create and maintain programming specifications; support creation and validation of submission requirements; provide programming support for statistical ad-hoc requests; participate in department working groups for tool development.
Seniority
Principal, hands-on IC with project leadership