Job Description
Responsibilities:
- Review and ensure accurate and high-quality statistical programming deliverables from CRO.
- Perform generation, validation and QC/QA of SDTM, ADam and TFL output in accordance with SOPs, SOIs, and guidance documents.
- Create and maintain specifications as per SDTM/ADaM standard and study SAP.
- Define and create ad-hoc reports and listings for clinical teams.
- Develop, implement and maintain SAS programming standards.
- Builds/tests programs for Data Validation, Derivation, and Data Reports to identify inconsistencies and support data review efforts, as necessary.
- Verifies completeness of relevant study deliverables prior to release from the group Maintains all required study documentation.
- Consults and provides input into system validation efforts including tool maintenance activities.
- Ensure CRF meets the guidelines o...