- Develop and validate SDTM domains for assigned studies.
- Generate SDTM validation reports and Pinnacle 21 compliance outputs.
- Prepare SDTM Reviewer’s Guide and related support documents.
ADaM Programming
- Create analysis-ready datasets and implement dataset specifications.
- Develop ADaM validation programs and traceability documentation.
- Produce statistical tables, patient listings, safety figures, CSR outputs, and interim analysis deliverables.
Programming Quality
- Maintain programming review checklists and validation reports.
- Generate quality metrics reports and standard macro documentation.
Data Management & Reconciliation
- Prepare data review listings, missing data reports,
and protocol deviation listings.
- Support query management metrics, SAE reconciliation, PK sample reconciliation, and external lab reconciliation.
- Handle eCOA/Paper COA reconciliation reports.