Senior / Principal Statistical Programmer with Minimum (6 Months to 1 Year) of R programming.
Experience
- Senior Statistical Programmer: 7+ years
- Principal Statistical Programmer: 9+ years
Role Summary
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; Minimum 1 Year of R programming.
- Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.
- Good understanding of CDISC standards and clinical trial processes.
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