Senior Statistical Programmer Lead Clinical Data

Cytel; Juneau (AK); Remote; USD 140,000 - 200,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work fully embedded with a pharmaceutical client, under Cytel guidance. You will lead SDTM/ADaM development, oversee CROs, support regulatory submissions, and ensure high-quality statistical programming across trials.

The role requires 7+ years of experience, expert SAS skills, CDISC mastery, and strong communication with regulatory interactions. On-site work with a rigorous, collaborative environment is expected.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma or similar.
• Exceptional SAS programming skills and CDISC (SDTM/ADaM/Define.xml) expertise.
• Experience with regulatory submissions and FDA/ICH guidelines.
• Ability to work independently and lead teams.
• Strong written and spoken communication and leadership.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for clinical programs.
• Oversee CRO deliverables and ensure timelines.
• Support study reports, regulatory submissions, DSURs and analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Create and maintain programming standards and macros.
• Collaborate with CROs, vendors, and partners.
• Review SOPs and work instructions for programming practices.

Skills

SAS programming

Independent work

Leadership

Communication

CDISC standards SDTM/ADaM

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work fully embedded with a pharmaceutical client, under Cytel guidance. You will lead SDTM/ADaM development, oversee CROs, support regulatory submissions, and ensure high-quality statistical programming across trials.

The role requires 7+ years of experience, expert SAS skills, CDISC mastery, and strong communication with regulatory interactions. On-site work with a rigorous, collaborative environment is expected.