Company: Katalyst Healthcares & Life Sciences
Posted on: January 25, 2023
- Perform SDTM mapping and create SDTM annotated CRF. Create SDTM
domain specifications, and develop/update SDTM company standard
- Develop SDTM domain based on SDTM specifications, or perform
programmatic review of study SDTM domains generated by vendor and
ensure SDTM deliverable quality.
- Provide CDISC SDTM expertise to study team and ensure CDISC
compliance in submission SDTM data package. Support submission team
in quick turnaround in response to regulatory agencies questions,
regarding SDTM development and validation.
- Support build compound SDTM programming convention. Maintain
institutional knowledge from SDTM history, and support building up
programming standard on SDTM to improve efficiency and quality.
Develop and manage CRO to ensure SDTM programming support with
efficiency, quality and completeness.
- Must have at least 5+ years of strong SDTM Study Data
Tabulation Model (SDTM) development and programming
- Knowledge in clinical trials with 5+ years' experience working
in a clinical project team environment meeting deadlines with
- SAS experience in major pharma or CRO.
- Proficient computer skills across multiple applications and OS
- Experience developing and working with company SDTM standards.
Experiences working with CRO vendor.
Keywords: Katalyst Healthcares & Life Sciences, Trenton , SAS Programmer, IT / Software / Systems , Trenton, New Jersey
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