Senior Statistical Programmer (Remote) – SDTM/ADaM Expert

Cytel; Atlanta (GA); Remote; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer fully embedded with one of our pharmaceutical clients in the United States. This role focuses on delivering high-quality programming for clinical development programs across therapeutic areas, with independence and ownership.

You will lead development of SDTM/ADaM, define.xml, reviewer’s guides, and complex outputs, while guiding CROs to maintain timelines and standards. Strong SAS skills and regulatory submission experience are essential.

Qualifications

• 7+ years of experience as a Statistical Programmer in biotech/pharma development.
• Extensive CDISC SDTM/ADaM experience and Define.xml.
• Experience supporting regulatory submissions and FDA interactions.
• Strong communication and leadership abilities.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, and define.xml for studies.
• Develop SAS programs for tables, listings, and figures with analyses.
• Oversee CRO programming deliverables to meet timelines.
• Support clinical study reports and regulatory submissions.

Job description

Cytel is seeking a Principal Statistical Programmer fully embedded with one of our pharmaceutical clients in the United States. This role focuses on delivering high-quality programming for clinical development programs across therapeutic areas, with independence and ownership.

You will lead development of SDTM/ADaM, define.xml, reviewer’s guides, and complex outputs, while guiding CROs to maintain timelines and standards. Strong SAS skills and regulatory submission experience are essential.