Senior Statistical Programmer – SDTM/ADaM Expert

Cytel; Cheyenne (WY); Remote; USD 130,000 - 180,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work embedded with one of our pharmaceutical clients, delivering high-quality data analyses and reporting under tight timelines.

You will lead SAS-based programming, oversee CRO deliverables, and contribute to regulatory submissions while ensuring compliance with FDA/ICH guidelines. Strong independence and leadership are required for success in this sponsor-dedicated role.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently with strong written and verbal communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to produce datasets, complex listings, tables, and graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CRO statistical programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions, including DSUR and exploratory analyses.
• Ensure compliance with FDA regulations, GCP, and electronic submission guidelines.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specs for external vendor data.
• Collaborate with CROs, vendors, and partners to meet project goals.
• Review and/or author SOPs and work instructions for programming practices.

Skills

SAS programming

Leadership

Communication

Independent work

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work embedded with one of our pharmaceutical clients, delivering high-quality data analyses and reporting under tight timelines.

You will lead SAS-based programming, oversee CRO deliverables, and contribute to regulatory submissions while ensuring compliance with FDA/ICH guidelines. Strong independence and leadership are required for success in this sponsor-dedicated role.