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Efficacy Clinical Programmer (Remote)

Company: Tandym Group
Location: Princeton
Posted on: May 27, 2023

Job Description:

A pharmaceutical company in New Jersey has a great Remote opportunity awaiting a new Efficacy Clinical Programmer. In this role, the Efficacy Clinical Programmer (Remote) will be responsible for SAS programming support for clinical trials analysis and reporting. Responsibilities: The Efficacy Clinical Programmer (Remote) will:

  • Independently develop and validate programs that generate analysis datasets based on ADaM specifications
  • Prepare/QC ADaM datasets documentation: Define.xml, Reviewer's Guide and analysis metadata report
  • Independently develop/validate programs that generate tables, listings and graphs specified in the protocol or the Statistical Analysis Plan (SAP) including efficacy statistical analysis
  • Perform quality control on final reports
  • Provide QC and validation reports
  • Support development of technical programming specifications for ADaM standards
  • Communicate with programming and statistics leads, data managers and other team members
  • Provide project progress updates of programming activities
  • Perform other duties, as needed Qualifications:
    • 8+ years of Statistical Programming experience in Biotechnology, Contract Research, and/or Pharmaceutical industry
    • Bachelor's Degree in Biostatistics, Computer Science, Mathematics or Life Sciences
    • Strong SAS programming skills required in Windows & UNIX environment
    • Proficiency in SAS/Base, SAS Macros, SAS/Stat
    • Principal level SAS programming skills with experience programming efficacy datasets and outputs
    • Good knowledge of industry standards including CDISC data structures (SDTM and ADaM)
    • Solid understanding of the Drug Development process (Phase 1 - 4)
    • Experience in reviewing CRF, SAP, output mock shells and Protocols from programming perspective
    • Experience in developing CDISC compliant ADaM specifications
    • Experience in validating ADaMs and TFLs
    • Strong knowledge on SAS macros and able to work on modifying/existing SAS programs
    • Great interpersonal skills
    • Excellent communication skills (written and verbal)
    • Strong atteniton to detail
    • Highly organized Desired Skills:
      • Experience with all Clinical Phases I, II, III and IV of trials
      • Experience with creating PK datasets and outputs (ADPC and ADPP), generating datasets for PK analysis
      • Experience in CNS
      • Nephrology experience
      • Submission experience
      • Knowledge of working in SAS Grid environment
      • Experience in SAS Enterprise Guide and SAS Studio

Keywords: Tandym Group, Trenton , Efficacy Clinical Programmer (Remote), IT / Software / Systems , Princeton, New Jersey

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