Senior Principal Statistical Programmer - Remote (SAS + R)

Faircape; South Africa; Remote; ZAR 1,495,000 - 2,492,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, supporting data reporting and regulatory submissions. The role focuses on SAS and R programming, SDTM/ADaM, and coordination with CROs to ensure high-quality outputs.

The candidate will develop and validate programs for analyses, tables, listings, and figures, while aligning with FDA/ICH guidelines and project timelines across multiple studies.

Qualifications

• Bachelor's degree in CS/Data Science/Math/Stats or equivalent preferred.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development.
• Expert SAS programming and SDTM/ADaM/CDISC knowledge.
• Experience with regulatory submissions and FDA/ICH guidelines.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions, DSURs, and analyses.
• Follow GCP and electronic submission guidelines; maintain programming standards.
• Contribute to data transfer specs and data validation plans.
• Collaborate with CROs, vendors and internal teams to meet project goals.

Skills

Leadership

Communication

Independent work

Regulatory understanding

Education

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

Tools

SAS

R

CDISC SDTM/ADaM

Define.xml

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely, embedded with a pharmaceutical client, supporting data reporting and regulatory submissions. The role focuses on SAS and R programming, SDTM/ADaM, and coordination with CROs to ensure high-quality outputs.

The candidate will develop and validate programs for analyses, tables, listings, and figures, while aligning with FDA/ICH guidelines and project timelines across multiple studies.