Senior Statistical Programmer — SDTM/ADaM Lead

Cytel; Montpelier (VT); Remote; USD 120,000 - 160,000; Full time

Job summary

Cytel seeks a Principal Statistical Programmer to lead SDTM/ADaM development and reporting for sponsor clinical trials. You will generate definitions, datasets, and complex outputs while guiding CRO work and ensuring high-quality, regulatory-compliant deliverables across multiple studies.

The role requires senior SAS skills, CDISC standards mastery, and proven leadership along with effective communication in a fast-paced biostatistics environment.

Qualifications

• Bachelor’s degree in a relevant field (CS/Data Science/Statistics/Math).
• 7+ years of experience as a Statistical Programmer in biotech/pharma.
• Expert SAS programming and CDISC SDTM/ADaM experience.
• Experience with regulatory submissions and FDA/ICH guidelines.

Responsibilities

• Generate SDTM and ADaM specifications and datasets.
• Develop SAS programs for complex listings, tables, and graphs.
• Deliver high-quality programming outputs for sponsor trials.
• Oversee CRO programming deliverables and timelines.
• Support clinical study reports, regulatory submissions, and publications.
• Follow FDA regulations and good clinical practice guidelines.
• Create and maintain standards for programming tools and macros.
• Collaborate with CROs and vendors to meet project goals.
• Review SOPs and work instructions related to statistical programming.

Skills

SAS programming

CDISC SDTM

CDISC ADaM

Define.xml

Regulatory submissions

Independent work

Leadership

Communication skills

Education

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

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

git

Job description

Cytel seeks a Principal Statistical Programmer to lead SDTM/ADaM development and reporting for sponsor clinical trials. You will generate definitions, datasets, and complex outputs while guiding CRO work and ensuring high-quality, regulatory-compliant deliverables across multiple studies.

The role requires senior SAS skills, CDISC standards mastery, and proven leadership along with effective communication in a fast-paced biostatistics environment.