Principal Statistical Programmer (SAS & R) - Remote

Placements24; East London; Remote; ZAR 900.000 - 1.300.000; Vollzeit

Zusammenfassung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join a sponsor-dedicated remote program. You will work on global clinical development projects, oversee CRO programmers, and ensure high-quality data summaries delivered on time.

The role requires expert SAS programming, CDISC standards (SDTM, ADaM, Define.xml), and experience with regulatory submissions. You will develop programs, specs, listings and supporting study reports with independence and leadership.

Qualifikationen

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development or similar.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive applied experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and interacting with FDA/global regulatory authorities.
• Must be able to work independently; excellent written and verbal communication; strong leadership.

Aufgaben

• Generate SDTM, ADaM specifications, datasets, reviewer's guides, and Define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results and maintain SAS/R programs.
• Oversee CROs' statistical programming deliverables and ensure timelines.
• Support preparation of CSRs, regulatory submissions, publications, DSURs, and exploratory analyses.
• Follow FDA regulations and good clinical practice for electronic submissions.
• Contribute to standards, tools, and macros; collaborate with internal/external partners.

Kenntnisse

Leadership

Communication

Independence

Ausbildung

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Jobbeschreibung

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) to join a sponsor-dedicated remote program. You will work on global clinical development projects, oversee CRO programmers, and ensure high-quality data summaries delivered on time.

The role requires expert SAS programming, CDISC standards (SDTM, ADaM, Define.xml), and experience with regulatory submissions. You will develop programs, specs, listings and supporting study reports with independence and leadership.