Job at a glance
You will own the end-to-end statistical programming for clinical data deliverables, from CRF design through Electronic Submission components. This role is on-site. Responsibilities Perform hands-on SAS programming to create and QC clinical Tables, Listings, and Graphs (TLFs). Validate and QC programs, datasets, and statistical reports according to specific study requirements. Author SDTM and ADaM dataset specifications, identifying potential data issues early in the process.
Work with Biostatistics to define and document programming endpoint algorithms. Deliver end-to-end programming for regulatory submissions per ICH and FDA/EMEA/ROW guidelines. Required Skills 7+ years of statistical programming experience in the life science industry. Expert-level proficiency in SAS statistical software. Strong knowledge of CDISC standards, specifically SDTM and ADaM. Experience producing TLFs, outputs, and reports, including rigorous QC.
Familiarity with drug development processes and clinical trial workflows. Proficiency with JMP and R, in addition to SAS. BS degree preferred.