Principal Statistical Programmer (SAS/R) - Remote

Datafin It Recruitment; Gauteng; Remote; ZAR 1,100,000 - 1,500,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within a global pharmaceutical client, supported by Cytel. The role focuses on delivering compliant SDTM/ADaM specs, datasets, and define.xml, and overseeing CRO programmers to ensure high-quality outputs and timely delivery.

The ideal candidate has 7+ years of experience in statistical programming, expert SAS skills, CDISC standards expertise, and a track record of regulatory submissions and

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• SAS programming expert with CDISC SDTM/ADaM and Define.xml.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and lead CROs.

Responsibilities

• Generate SDTM, ADaM specs, datasets, define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming outputs for regulatory submissions.
• Oversee CROs’ statistical programming deliverables to ensure timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

SAS programming

CDISC SDTM

CDISC ADaM

FDA submissions

R programming

Leadership

GCP knowledge

Education

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

Tools

SAS

R

Python

Unix/Linux

git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on a sponsor-dedicated basis within a global pharmaceutical client, supported by Cytel. The role focuses on delivering compliant SDTM/ADaM specs, datasets, and define.xml, and overseeing CRO programmers to ensure high-quality outputs and timely delivery.

The ideal candidate has 7+ years of experience in statistical programming, expert SAS skills, CDISC standards expertise, and a track record of regulatory submissions and