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Clinical SAS Programmer

Clinical SAS Programmer

Katalyst HealthCares & Life SciencesPhiladelphia, PA
30+ days ago
Job type
  • Full-time
Job description

Responsibilities :

  • Attending multi-disciplinary team meetings, representing the programming function.
  • Create or review and approve programming plans at study and project level.
  • Provide input on key study-related documents produced by other functions ( CRFs, Data Management Plan, SAPs, etc.)
  • Create or review and approve CDISC-compliant datasets and corresponding documentation for electronic submission to regulatory agencies.
  • Develop software systems to generate displays of clinical 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.

Requirements :

  • Minimum of 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 .
  • Solid verbal and written communication skills.
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    Programmer • Philadelphia, PA