Principal Statistical Programmer: Lead SDTM/ADaM

Cytel; Cheyenne (WY); On-site; USD 120,000 - 180,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer embedded with a global pharmaceutical client. You will work independently on broad programming tasks, leading development of SDTM/ADaM datasets, tables and graphs while ensuring compliance with FDA guidelines.

You will mentor others, deliver high-quality outputs, and collaborate with CROs and vendors. Strong SAS/R skills and CDISC standards are essential; FDA submission experience is highly valued.

Qualifications

• Bachelor's degree in CS, data science, mathematics or statistics is preferred.
• 9+ years as Statistical Programmer in biotech/pharma clinical biometrics or similar team.
• SAS/R programming skills with experience in clinical development standards.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and lead through technical expertise.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml for multiple studies.
• Support FDA submissions and regulatory reporting requirements.
• Lead development of SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality programming outputs and validate SAS/R programs.
• Oversee programming deliverables across studies to meet timelines.
• Contribute to clinical study reports, regulatory submissions, publications and DSURs.
• Develop and maintain standards for programming tools, outputs and macros.
• Review or author data transfer specs for external vendors.
• Collaborate with CROs and vendors to meet project timelines.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Leadership

Regulatory submissions

Independent work

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

Unix/Linux

Git

Python

Job description

Cytel seeks a Principal Statistical Programmer embedded with a global pharmaceutical client. You will work independently on broad programming tasks, leading development of SDTM/ADaM datasets, tables and graphs while ensuring compliance with FDA guidelines.

You will mentor others, deliver high-quality outputs, and collaborate with CROs and vendors. Strong SAS/R skills and CDISC standards are essential; FDA submission experience is highly valued.