Principal Statistical Programmer (Remote) – SAS + R

Department Of Education Tasmania; South Africa; Remote; ZAR 1,994,000 - 2,991,000; Full time

Job summary

Cytel Inc. in a fully remote senior role is seeking a Senior/Principal Statistical Programmer.

The sponsor-dedicated position embeds you with one pharmaceutical client, giving autonomy and ownership while Cytel provides ongoing support and standards. You will generate SDTM/ADaM specs, write SAS and R programs, review CRO deliverables, assist in CSR, regulatory submissions, DSURs and exploratory analyses, and ensure compliance with FDA/ICH guidelines.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years of experience as a Statistical Programmer on biotech/pharma clinical development.
• Exceptional SAS programming skills in a clinical development environment.
• CDISC SDTM/ADaM standards and regulatory knowledge (FDA/ICH).
• Experience with regulatory submissions and interactions with authorities.

Responsibilities

• Generate SDTM, ADaM specifications and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality programming results and validate SAS/R code.
• Oversee CRO deliverables to ensure timelines and quality.
• Support clinical study reports, regulatory submissions, DSURs and analyses.
• Adhere to FDA regulations and good clinical practice.
• Contribute to standards for tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent worker

Leadership

Education

Bachelor’s degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. in a fully remote senior role is seeking a Senior/Principal Statistical Programmer.

The sponsor-dedicated position embeds you with one pharmaceutical client, giving autonomy and ownership while Cytel provides ongoing support and standards. You will generate SDTM/ADaM specs, write SAS and R programs, review CRO deliverables, assist in CSR, regulatory submissions, DSURs and exploratory analyses, and ensure compliance with FDA/ICH guidelines.