Lead Statistical Programmer — Clinical Data & Submissions

Cytel; Montpelier (VT); On-site; USD 140,000 - 190,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharma client, delivering high-quality SDTM/ADaM outputs and leading programming teams. You will develop, validate, and maintain SAS and R programs for diverse clinical development programs.

You will collaborate with CROs and vendors, support regulatory submissions, and contribute to standards and tools used across studies. Strong leadership and independent work are essential.

Qualifications

• Bachelor's degree in CS, data science, math or statistics
• 9+ years as Statistical Programmer in Biotech/Pharma
• SAS/R programming in clinical development
• Experience with CDISC SDTM/ADaM/Define.xml
• Experience with regulatory submissions (FDA/ICH)

Responsibilities

• Generate SDTM and ADaM specifications and define.xml for multiple studies
• Lead SAS/R programming to create datasets, listings, tables, graphs
• Ensure high-quality outputs meeting timelines
• Prepare clinical study reports and regulatory submissions
• Develop and maintain programming standards and macros
• Collaborate with CROs and vendors to meet project goals
• Provide oversight to junior programmers

Skills

SAS/R programming

Communication skills

Leadership

Independent work

Problem solving

Education

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

Tools

R

Python

Java

Shiny

Git

Unix/Linux

Markdown

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharma client, delivering high-quality SDTM/ADaM outputs and leading programming teams. You will develop, validate, and maintain SAS and R programs for diverse clinical development programs.

You will collaborate with CROs and vendors, support regulatory submissions, and contribute to standards and tools used across studies. Strong leadership and independent work are essential.