Description

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.

Key Skills

Education

Any Gradute