Remote Principal Statistical Programmer – SDTM/ADaM Lead

Cytel; Santa Fe (NM); Remote; USD 140,000 - 170,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work within the FSP Services unit on sponsor-driven programs in the U.S. You will lead SDTM/ADaM work, develop complex SAS code and ensure high-quality data deliverables for regulatory submissions.

This role involves independent work, collaboration with CROs, and adherence to FDA guidelines. Ideal candidates will have 7+ years in biotech/pharma programming, strong SAS expertise, and experience with CDISC standards.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer on Biotech/Pharma programs.
• Exceptional SAS programming skills and FDA/ICH regulatory knowledge.
• CDISC SDTM/ADaM, Define.xml expertise and data submission experience.
• Ability to work independently and lead with strong communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality programming results and validate SAS/R code.
• Oversee CRO programming deliverables and ensure timelines.
• Support clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations, GCP and electronic submission guidelines.
• Create and maintain standards for tools, outputs, and macros.
• Develop CRFs, edit checks, data validation plans, and data transfer specs.
• Collaborate with CROs, vendors, and clinical partners to meet goals.

Skills

SAS programming

Leadership

Independent work

Regulatory submissions

Excellent communication

Education

Bachelor's degree in computer science / data science / mathematics / statistics

Tools

R

Python

SAS

Job description

Cytel is seeking a Principal Statistical Programmer to work within the FSP Services unit on sponsor-driven programs in the U.S. You will lead SDTM/ADaM work, develop complex SAS code and ensure high-quality data deliverables for regulatory submissions.

This role involves independent work, collaboration with CROs, and adherence to FDA guidelines. Ideal candidates will have 7+ years in biotech/pharma programming, strong SAS expertise, and experience with CDISC standards.