Principal Statistical Programmer (SAS + R) — Clinical

Cytel; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer to work within a sponsor-dedicated team in Cape Town. You will manage SDTM, ADaM, define.xml artifacts, generate complex listings and graphs in SAS and R, and oversee CRO deliverables for multiple studies.

You will contribute to regulatory submissions, DSURs, and exploratory analyses while ensuring compliance with FDA/ICH guidelines and good clinical practice. A strong independent work style and leadership are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development or similar.
• Exceptional SAS programming skills with clinical development experience.
• Hands-on R programming experience.
• Extensive CDISC SDTM/ADaM and Define.xml knowledge; FDA/ICH regulations familiar.
• Experience supporting regulatory submissions and interactions with regulators.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewer's guides, and define.xml for multiple studies.
• Develop SAS programs for datasets, complex listings, tables, and graphs with statisticians.
• Deliver high-quality programming outputs; validate and maintain SAS and/or R programs.
• Oversee CRO programming deliverables across studies to meet timelines.
• Support preparation of CSRs, regulatory submissions, publications, DSUR, and exploratory analyses.
• Follow FDA regulations and GxP guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; review data transfers.
• Collaborate with internal/external partners (CROs, vendors, sponsors) to meet goals.
• Review and/or author SOPs and work instructions for programming practices.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Independence

Leadership

Communication skills

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer to work within a sponsor-dedicated team in Cape Town. You will manage SDTM, ADaM, define.xml artifacts, generate complex listings and graphs in SAS and R, and oversee CRO deliverables for multiple studies.

You will contribute to regulatory submissions, DSURs, and exploratory analyses while ensuring compliance with FDA/ICH guidelines and good clinical practice. A strong independent work style and leadership are essential.