Remote Principal Statistical Programmer - SDTM/ADaM Expert

Staff Unlimited Recruitment; South Africa; Remote; ZAR 900,000 - 1,800,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one of our pharmaceutical clients. You will lead programming efforts, develop SDTM/ADaM datasets, and supervise CRO programmers to ensure high-quality data outputs and timely submissions.

Reporting to the Director, Biostatistics and Programming, you will implement reporting and analyses, maintain programming standards, and contribute to regulatory submissions, DSURs and study reports.

Qualifications

• Bachelor's degree in a quantitative field or statistics.
• 7+ years of experience as Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills for clinical development.
• CDISC SDTM/ADaM expertise and Define.xml experience.
• Experience with regulatory submissions and FDA/ICH considerations.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewer’s guides and define.xml files.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs for regulatory submissions and studies.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, DSURs, publications and exploratory analyses.
• Collaborate with internal/external partners to ensure project goals.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

R programming

Leadership

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with one of our pharmaceutical clients. You will lead programming efforts, develop SDTM/ADaM datasets, and supervise CRO programmers to ensure high-quality data outputs and timely submissions.

Reporting to the Director, Biostatistics and Programming, you will implement reporting and analyses, maintain programming standards, and contribute to regulatory submissions, DSURs and study reports.