Principal Statistical Programmer

Plainsboro, New Jersey

Katalyst Healthcares and Life Sciences
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Responsibilities:
  • 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.
  • Develop software systems to generate displays of clinical study data as tables, listings, and graphs for electronic submission to regulatory agencies.
  • ssist 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.
  • Oversee work of internal contract programmers and external vendors.
  • Provide time and resource estimates for project planning.
Requirements:
  • Minimum of 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 Oncology 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 modelling a plus.
  • Familiarity with CDISC standards, including SDTM and Adam models. Solid verbal and written communication skills.
Date Posted: 26 May 2025
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