• Principal Clinical Data Standards Consultant

    Job Locations (All) | US-Remote
    Posted Date 2 weeks ago(11/30/2018 9:12 AM)
  • Responsibilities

    • Developing and maintaining SDTM library standards that are used across all Sponsor TAs. This includes but is not limited to:
      • CDISC SDTM mapping of data collections and concepts
      • Defining and maintaining Data Definition -, Variable Definition-, Value Level -, Where Clause, Methods Metadata
      • Working with MS Excel and SAS and in the future Sycamore’s MDR in development of library standards
    • Applies standardized controlled terminology to the Sponsor SDTM standards
      • CDISC controlled terminology (quarterly releases)
      • Sponsored Controlled terminology
      • Support the Sponsor Controlled terminology standard versioning process (2x per year)
    • The scope includes:
      • Global standards (Cross therapeutic area), Questionnaires and rating scales and disease area specific standards (Therapeutic Area specific)
      • Hierarchy of global and therapeutic area specific preconfigured SDTM libraries
    • Provide the support to the TA leads at Janssen who are working directly with the clinical team representatives
      • Specifically, process change request to the SDTM library, do the preparation work to expedite CR processing
      • Back-up a TA lead providing SDTM mapping and attending cross functional meetings when needed





    • Deep CDISC CDASH and SDTM (specifically SDTM IG 3.2) expertise
    • SAS programming knowledge and expertise
    • Metadata Standards development (SDTM) expertise
    • Handle multiple tasks and prioritize accordingly
    • Track record of delivering according to plan
    • Has excellent communication skills, verbal and written
    • Can work autonomously in a cross functional environment



    • Cross Therapeutic Area experience
    • Global work experience
    • SAS LSAF experience
    • Therapeutic Area specific SDTM expertise is a plus (e.g. TAUG)
    • Experience with biomedical concepts is a plus.

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.


    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Connect With Us!

    Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!