Clinical SAS programmer - Katalyst Healthcares and Life Sciences : Job Details

Clinical SAS programmer

Katalyst Healthcares and Life Sciences

Job Location : Chicago,IL, USA

Posted on : 2025-08-05T07:34:13Z

Job Description :
Responsibilities:
  • Create or review and approve programming plans at study and project level.
  • Provide input on key study-related documents produced by other functions (e.g. CRFs, Data Management Plan, SAPs, etc.)
  • Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
  • Attending multi-disciplinary team meetings, representing the programming function.
  • Develop software systems to generate displays of clinal al study data as tables, listings, and graphs for electronic submission to regulatory agencies.
  • Assist statisticians by suggesting algorithms to address Client analysis requests.
  • Develop software validation procedures and test plans, as necessary.
  • Create and document archives of software, outputs, and analysis files.
  • Create and maintain department SOPs related to clinical programming.
  • Review draft clinical reports, journal articles, slide presentations, and other documents to assure that results are reported accurately.
  • Provide time and resource estimates for project planning.
  • Oversee work of internal contract programmers and external vendors.
Requirements:
  • Bachelor's degree in computer science, Statistics, Mathematics, Life Sciences or other relevant scientific fields; master's degree preferred.
  • Minimum 6 years of experience in developing software for clinical trials using the SAS system
  • Skilled in programming with SAS, Knowledge of additional programming languages a plus.
  • Good knowledge of statistics and drug development process
  • Experience as a lead programmer for NDAs/BLAs
  • Experience overseeing the work of internal contractors and external vendors (CROs)
  • Experience in pharmacokinetics/pharmacodynamics modeling a plus.
  • Familiarity with CDISC standards, including SDTM and ADaM models.
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