Senior Statistical Programmer - Clinical Trials Lead

Cytel; Providence (RI); Remote; USD 120,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer, embedded with a pharmaceutical client, to drive SDTM/ADaM workstreams and deliver high-quality analysis outputs with minimal supervision.

The role focuses on SAS programming, complex listings and graphs, and oversight of CRO programmers, supporting regulatory submissions under FDA guidelines. Strong leadership and communication are essential.

Qualifications

• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and graphs
• Deliver high-quality programming results and maintain SAS/R programs for clinical programs
• Oversee CRO programmers to ensure timely, high-quality deliverables
• Support preparation of Clinical Study Reports, regulatory submissions, and exploratory analyses
• Understand and apply FDA regulations for electronic submissions

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independence

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer, embedded with a pharmaceutical client, to drive SDTM/ADaM workstreams and deliver high-quality analysis outputs with minimal supervision.

The role focuses on SAS programming, complex listings and graphs, and oversight of CRO programmers, supporting regulatory submissions under FDA guidelines. Strong leadership and communication are essential.