Principal Statistical Programmer – Remote

Department Of Education Tasmania; South Africa; Remote; ZAR 1,200,000 - 1,900,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will own programming for SDTM/ADaM, create define.xml, and deliver complex datasets and reports across multiple studies.

You will lead CRO programming efforts, ensure timelines, and support regulatory submissions with strong SAS/R expertise. The role requires 7+ years in biotech/pharma programming, extensive CDISC experience, and the ability to work independently

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming with CDISC SDTM/ADaM/Define.xml experience.
• Experience supporting regulatory submissions and interactions with authorities.

Responsibilities

• Generate SDTM, ADaM specs, datasets, define.xml and reviewer's guide.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programming tailored to trials.
• Oversee CROs' programming deliverables to meet timelines.
• Support clinical study reports, regulatory submissions and DSURs.
• Ensure compliance with FDA/ICH regulations and standards.
• Develop and validate programming tools, macros and standards.
• Contribute to CRFs, edit checks and data validation plans.

Skills

SAS programming

Statistical programming

Leadership

Communication

Independent work

Education

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

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical clinical development programs. You will own programming for SDTM/ADaM, create define.xml, and deliver complex datasets and reports across multiple studies.

You will lead CRO programming efforts, ensure timelines, and support regulatory submissions with strong SAS/R expertise. The role requires 7+ years in biotech/pharma programming, extensive CDISC experience, and the ability to work independently