Principal Statistical Programmer - Lead in FDA Submissions

Cytel; Austin (TX); On-site; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality statistical programming with autonomy and ownership. You will oversee SDTM/ADaM development, regulatory submissions, and cross-functional collaboration to support trial data and DR submissions.

The role emphasizes leadership, independence, and the use of SAS/R in a clinical development setting, with opportunities to influence standards and best practices across studies.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 9+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS/R programming skills for clinical development environments.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently and lead with strong communication.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Follow FDA regulations affecting clinical trial data reporting across submissions.
• Lead and support SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality programming results with SAS and/or R for development programs.
• Oversee programming deliverables for multiple studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, and exploratory analyses.
• Contribute to standards for programming tools, outputs, and macros.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs and vendors to meet project goals.

Skills

SAS programming

R programming

Leadership

Regulatory submissions

Independent work

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Python

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering high-quality statistical programming with autonomy and ownership. You will oversee SDTM/ADaM development, regulatory submissions, and cross-functional collaboration to support trial data and DR submissions.

The role emphasizes leadership, independence, and the use of SAS/R in a clinical development setting, with opportunities to influence standards and best practices across studies.