Principal Statistical Programmer – SAS + R (Remote)

Mediclinic; Stellenbosch; Remote; ZAR 1,000,000 - 1,600,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a global pharmaceutical client. You will work with minimal supervision, deliver high-quality analyses, and guide CRO programmers to ensure timely, compliant outputs.

The role requires SDTM/ADaM, Define.xml, regulatory submissions support, and strong communication and leadership. A bachelor’s degree in a quantitative field and 7+ years of experience are preferred.

Qualifications

• Bachelor's degree in CS/DS/Math/Stats or related field.
• 7+ years as Statistical Programmer in biotech/pharma clinical development.
• Exceptional SAS programming skills in a clinical development environment.
• CDISC SDTM/ADaM/Define.xml expertise; regulatory submission experience.
• Experience with FDA/ICH regulations and ability to work independently.
• Strong written and verbal communication and leadership abilities.

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 SAS and R programs tailored to clinical development needs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and exploratory analyses.
• Adhere to FDA regulations and GCP for reporting.
• Contribute to creation and maintenance of programming standards and macros.
• Participate in development of CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals and timelines.

Skills

Communication

Leadership

Independent work

Regulatory knowledge

Education

Bachelor's degree in CS/DS/Math/Stats

Tools

SAS

R

Python

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a remote role embedded with a global pharmaceutical client. You will work with minimal supervision, deliver high-quality analyses, and guide CRO programmers to ensure timely, compliant outputs.

The role requires SDTM/ADaM, Define.xml, regulatory submissions support, and strong communication and leadership. A bachelor’s degree in a quantitative field and 7+ years of experience are preferred.