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