Principal Statistical Programmer (SAS & R) for Pharma

Cytel; South Africa; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel invites a Principal Statistical Programmer to join our embedded team with a pharmaceutical client, driving innovation and delivering high-quality statistical programming across studies. The role emphasizes autonomy, leadership, and collaboration, including oversight of CRO deliverables, development of SDTM/ADaM specifications, and support for regulatory submissions under FDA/ICH guidelines.

You will contribute to data standards, define.xml definitions, and program quality across diverse

Qualifications

• Bachelor's degree in a related field with 7+ years of programming experience in biotech/pharma.
• Expert SAS programming in a clinical development environment.
• Deep knowledge of CDISC SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions with FDA/ICH.
• Ability to work independently and lead CRO programming teams.
• Strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality statistical programming results with SAS and/or R.
• Oversee CRO’s programming deliverables to meet timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Ensure compliance with FDA regulations and GCP for reporting.
• Contribute to standards for programming tools, outputs, and macros.
• Participate in data validation plans and data transfer specifications.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Independent work

Communication skills

Education

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel invites a Principal Statistical Programmer to join our embedded team with a pharmaceutical client, driving innovation and delivering high-quality statistical programming across studies. The role emphasizes autonomy, leadership, and collaboration, including oversight of CRO deliverables, development of SDTM/ADaM specifications, and support for regulatory submissions under FDA/ICH guidelines.

You will contribute to data standards, define.xml definitions, and program quality across diverse