Senior CDISC programmer

1. Develop and maintain CDISC-compliant datasets, including SDTM and ADaM, in accordance with CDISC standards and study specifications.
2. Perform data mapping and programming to convert raw clinical trial data into SDTM and ADaM datasets using SAS or other programming tools.
3. Prepare and maintain CDISC-related documentation, including SDTM Mapping Specifications, ADaM Specifications, Define.xml, and Reviewer’s Guides (SDRG/ADRG).
4. Ensure compliance with CDISC standards and regulatory requirements (e.g., FDA, PMDA) for clinical trial data submissions.
5. Conduct dataset validation and quality checks using tools such as Pinnacle21 or equivalent validation software to ensure dataset accuracy and CDISC compliance.
6. Collaborate with cross-functional teams, including Biostatisticians, Data Management, Clinical Operations, and Sponsors, to support data standardization and analysis needs.
7. Develop and maintain internal programming standards, macros, and automated processes to improve programming efficiency and consistency.
8. Provide technical leadership and mentorship to junior programmers, including code review and guidance on CDISC implementation.
9. Support regulatory submissions by preparing submission-ready datasets, metadata, and related documentation for regulatory authorities.
10. Stay current with updates to CDISC standards and industry best practices and contribute to the continuous improvement of programming processes and standards.