Principal Statistical Programmer (Remote) – SAS & R

Department of Health; Gauteng; Remote; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM, develop SAS programs, and oversee CRO deliverables to ensure timely, high-quality data outputs.

You will contribute to study reports, regulatory submissions, and exploratory analyses, while adhering to FDA/ICH guidelines and data standards. Strong independence, leadership, and communication are essential.

Qualifications

• At a minimum a bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and engaging with regulators.
• Ability to work independently and lead others with strong communication.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver SAS/R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of study reports, regulatory submissions, DSUR, and analyses.
• Follow FDA/ICH regulations for electronic submissions and data handling.
• Create and maintain standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership skills

Education

Bachelor's degree in CS/Data Science/Math/Stats

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote role embedded with a pharmaceutical client. You will lead programming activities across SDTM/ADaM, develop SAS programs, and oversee CRO deliverables to ensure timely, high-quality data outputs.

You will contribute to study reports, regulatory submissions, and exploratory analyses, while adhering to FDA/ICH guidelines and data standards. Strong independence, leadership, and communication are essential.