Vacancy expired!
- Perform SDTM mapping and create SDTM annotated CRF. Create SDTM domain specifications, and develop/update SDTM company standard specifications.
- 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 DS 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 DS 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 skills.
- Knowledge in clinical trials with 5+ years' experience working in a clinical project team environment meeting deadlines with quality deliverables.
- SAS experience in major pharma or CRO.
- Proficient computer skills across multiple applications and OS environments.
- Experience developing and working with company SDTM standards. Experiences working with CRO vendor.
Vacancy expired!