Senior Statistical Programmer / Principal Statistical Programmer

Senior / Principal Statistical Programmer

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; R knowledge is a plus.
• Hands-on experience with SDTM, ADaM, TLFs, and regulatory submissions.
• Good understanding of CDISC standards and clinical trial processes.

Leadership Requirements

• Senior Statistical Programmer: Mandatory co-lead study experience.
• Principal Statistical Programmer: Mandatory lead study experience.