Remote Principal Statistical Programmer (SAS + R)

Eems Dollard Regio; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-focused role. You will drive SDTM/ADaM coding, define.xml development, and complex outputs for regulatory submissions while collaborating with CROs and internal teams.

The position emphasizes leadership, independent work, and close alignment with FDA/ICH standards. The role requires 7+ years' experience, strong SAS and R skills, and extensive CDISC knowledge.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma or equivalent.
• Exceptional SAS programming skills and experience with statistical programming procedures.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA or global authorities.
• Ability to work independently and lead project components.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical development needs; validate and maintain them.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support preparation of studies reports, submissions, publications and DSURs.
• Contribute to development and maintenance of programming standards, tools, and SOPs.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulation

Leadership

Communication

Education

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

Tools

Python

Java

Shiny

Unix/Linux

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-focused role. You will drive SDTM/ADaM coding, define.xml development, and complex outputs for regulatory submissions while collaborating with CROs and internal teams.

The position emphasizes leadership, independent work, and close alignment with FDA/ICH standards. The role requires 7+ years' experience, strong SAS and R skills, and extensive CDISC knowledge.