Clinical SAS - SDTM

TechDigital

  • Upper Gwynedd, PA
  • 16 days ago
    Want to know if you’re a fit?
    Upload your resume and let our AI show you.

    Skills

    • Biostatisticsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Clinical Data Interchange Standards Consortium (CDISC)unmatched
    • Clinical Trialunmatched
    • Code Reviewsunmatched
    • Contract Research Organization (CRO)unmatched
    • Data Processingunmatched
    • Documentationunmatched
    • FDA (Food and Drug Administration)unmatched
    • ICH Regulationsunmatched
    • Maintain Complianceunmatched
    • Regulatory Complianceunmatched
    • Statistical Analysis System (SAS)unmatched
    • Traceabilityunmatched

    Description

    Looking for SDTM experts having in-depth knowledge of SAS programming(macro's)

    1.Must have 10+ yrs of exp in clinical domain
    2.Strong knowledge of SDTM
    3.Create advanced SAS macros, templates, and utilities for efficient data processing
    4.Act as the primary programming point of contact for biostatisticians and study teams
    5.Perform peer review of code and documentation for accuracy and traceability
    6.Review CRF (Case Report Form) annotations and data specifications.
    7.Ensure compliance with CDISC standards (SDTM/ADaM) and FDA/ICH guidelines

    Skill:
    1.Extensive programming experience in a clinical trial environment (CRO/Pharma).
    2.Expertise in SAS/BASE, SAS/STAT, and SAS/MACRO.
    3.In-depth knowledge of CDISC standards and regulatory submission requirements

    Numbers & Facts

    LocationUpper Gwynedd, PA
    IndustryOther/Not Classified
    Company Size100 to 499 employees

    Similar Jobs