Senior Statistical Programmer: SDTM/ADaM Expert

Cytel; Richmond (VA); Remote; USD 120,000 - 170,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering SDTM/ADaM specifications, datasets, and analyses. You will oversee CRO programming, implement regulatory-grade reporting, and contribute to standards and SOPs in a fast-paced biostatistics environment.

You should have a strong SAS/R toolkit, CDISC expertise, and a track record in regulatory submissions. Independence, leadership, and clear communication are essential in this senior role.

Qualifications

• Bachelor’s degree in CS/Data Science/Math/Stats (or equivalent) required/preferred.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and clinical development experience.
• Extensive experience with CDISC standards (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and deliver high-quality results.
• Excellent written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewer’s guides, and define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs for clinical development programs.
• Oversee CRO programmers to ensure high-quality deliverables on time.
• Support preparation of CSRs, regulatory submissions, publications, DSUR, and analyses.
• Follow FDA regulations and GCP for reporting clinical trial data.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; provide data transfer specs.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering SDTM/ADaM specifications, datasets, and analyses. You will oversee CRO programming, implement regulatory-grade reporting, and contribute to standards and SOPs in a fast-paced biostatistics environment.

You should have a strong SAS/R toolkit, CDISC expertise, and a track record in regulatory submissions. Independence, leadership, and clear communication are essential in this senior role.