Description

You will own the end-to-end statistical programming for clinical data deliverables.

Responsibilities

• Perform hands-on SAS programming for creating and QCing clinical Tables, Listings, and Graphs.
• Validate and QC programs, datasets, and statistical reports according to study requirements.
• Author SDTM and ADaM dataset specifications, identifying potential data issues.
• Work with Biostatistics to define and document programming endpoint algorithms.
• Deliver end-to-end programming from CRF design through Electronic Submission (ESUB) components.

Required Skills

• 7+ years of Statistical Programming experience in the life science industry.
• Expertise in SAS statistical software.
• Strong knowledge of CDISC (SDTM & ADaM).
• Experience supporting regulatory submissions per ICH and FDA/EMEA/ROW guidelines.
• Familiarity with drug development processes and clinical trials.
• Proficiency with JMP and R, in addition to SAS.
• Experience producing TLFs, outputs, and reports, including QC.
• BS degree is preferred.

Key Skills

Education

Any Gradute