Principal Statistical Programmer – FSP (Clinical Trials)

Cytel; Topeka (KS); Remote; USD 130,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client within Cytel’s FSP Services. You will lead SAS programming efforts for SDTM/ADaM deliverables, supervise CRO work, and contribute to regulatory submissions.

The role requires independent work, strong communication, and a senior level of expertise. You will collaborate with biostatistics and programming teams, ensure data quality, and support study reports and regulatory interactions while

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical biometrics.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC (SDTM/ADaM/Define.xml) experience.
• Experience with regulatory submissions and FDA interactions.
• Ability to work independently and lead teams.

Responsibilities

• Generate SDTM and ADaM specifications and define.xml for studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and meet timelines.
• Oversee CRO programming deliverables and collaborate with vendors.
• Support regulatory submissions, CSR creation and exploratory analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership/Communication

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Shiny

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client within Cytel’s FSP Services. You will lead SAS programming efforts for SDTM/ADaM deliverables, supervise CRO work, and contribute to regulatory submissions.

The role requires independent work, strong communication, and a senior level of expertise. You will collaborate with biostatistics and programming teams, ensure data quality, and support study reports and regulatory interactions while