Senior Statistical Programmer - FSP
Core
Design, develop, and quality control SAS programs to access, extract, transform, review, analyze, and submit clinical data for regulatory submissions.
Role type
Senior Statistical Programmer (Clinical Trials)
Builds
Submission-ready clinical data packages (ADaM, SDTM, tables, figures, listings) and global efficiency tools for the Statistical Programming group.
Domain
Clinical Research / Pharmaceutical / Life Sciences
Required skills
SAS programming, SAS Macros, R programming, CDISC standards (CDASH, SDTM, ADaM), statistical analysis, data structure design, quality control
Preferred skills
Pooled and exploratory analysis leadership, cross-functional team collaboration, regulatory agency response support
Technologies
SAS, R, CDISC standards
Responsibilities
Design data structures and specifications for ad hoc and study deliverables; ensure quality and accuracy of clinical data for submission readiness; lead pooled and exploratory analyses; develop complex SAS programs for CDISC ADaM format; develop global tools to increase group efficiency; support regulatory agency responses and publications.
Seniority
Senior, hands-on IC