Address
Form of work Responsibilities:
- 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 building 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.
