Senior Statistical Programmer – Clinical Trials Lead

Cytel; Tallahassee (FL); Remote; USD 120,000 - 180,000; Full time

Job summary

Cytel Inc. seeks a Principal Statistical Programmer to join a sponsor-dedicated program embedded with a pharmaceutical client. You will drive data reporting and analysis with autonomy, guiding CRO programmers to ensure high-quality outputs across studies.

Reporting to the Director of Biostatistics and Programming, you will develop SDTM/ADaM specifications, define.xml, and support regulatory submissions, while maintaining SAS and R programs tailored to clinical development needs.

Qualifications

• Bachelor's degree in CS, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills for clinical development environments.
• Extensive CDISC SDTM/ADaM/Define.xml experience and FDA/ICH regulation familiarity.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and Define.xml files for multiple studies.
• Develop SAS programs to produce datasets, complex listings, tables and graphs.
• Deliver high-quality programming results and maintain SAS/R programs for clinical programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks and data validation plans.

Skills

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Education

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

Tools

R

Python

Unix/Linux

Git

Job description

Cytel Inc. seeks a Principal Statistical Programmer to join a sponsor-dedicated program embedded with a pharmaceutical client. You will drive data reporting and analysis with autonomy, guiding CRO programmers to ensure high-quality outputs across studies.

Reporting to the Director of Biostatistics and Programming, you will develop SDTM/ADaM specifications, define.xml, and support regulatory submissions, while maintaining SAS and R programs tailored to clinical development needs.