Principal Statistical Programmer (SAS/R) — Remote

Firstrand Limited; Upington; Remote; ZAR 1,994,000 - 2,991,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with sponsor-dedicated pharmaceutical client engagement. The role involves independent, expert programming across SDTM/ADaM, Define.xml, and complex tables/graphs, with CRO oversight and regulatory submission support.

You will implement reporting and analysis activities for sponsor trials, ensure FDA/ICH compliance, and contribute to standards and documentation across projects.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma Clinical Development.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Experience with regulatory submissions and FDA/ICH regulation.
• Ability to work independently and lead others.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM/ADaM specs, datasets, reviewer’s guides, and define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs with statistics.
• Deliver high-quality SAS/R programs tailored to clinical development needs.
• Oversee CROs' programming deliverables to meet timelines.
• Support study reports, regulatory submissions, publications, and DSURs.
• Ensure compliance with FDA/GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Contribute to CRFs, edit checks, and data validation plans.
• Review and/or author data transfer specifications for external vendors.
• Collaborate with CROs, vendors, and partners to meet project goals.
• Draft SOPs/Work Instructions for statistical programming.

Skills

SAS programming

CDISC standards (SDTM/ADaM)

Regulatory submissions

Leadership/independence

Strong communication

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely with sponsor-dedicated pharmaceutical client engagement. The role involves independent, expert programming across SDTM/ADaM, Define.xml, and complex tables/graphs, with CRO oversight and regulatory submission support.

You will implement reporting and analysis activities for sponsor trials, ensure FDA/ICH compliance, and contribute to standards and documentation across projects.