Responsible for end-to-end statistical programming activities for clinical studies, from specification creation through regulatory submissions, ensuring high-quality and compliant deliverables.
Key Responsibilities
- Develop and validate SDTM, ADaM, and TLFs.
- Create and review programming specifications.
- Support regulatory submissions and ensure CDISC compliance.
- Perform QC and maintain programming standards.
- Collaborate with cross-functional teams and support study deliverables.
- Contribute to process improvements and mentoring activities.
Required Skills
- Strong SAS programming expertise
- Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.
- Positive understanding of CDISC standards and clinical trial processes.