Remote Principal Statistical Programmer (SAS + R)

Placements24; South Africa; Remote; ZAR 1,200,000 - 1,800,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated, embedded role for a global pharmaceutical client.

The role involves independently delivering high-quality programming for clinical trials, including SDTM/ADaM, define.xml, listings, and complex graphs. You will collaborate with CROs and internal teams, support regulatory submissions, 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 in biotech/pharma clinical development.
• Exceptional SAS programming skills with CDISC (SDTM/ADaM/Define.xml).
• Experience supporting regulatory submissions and interactions with FDA/ICH.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guides and define.xml files for multiple studies.
• Develop SAS programs for datasets, listings, tables and complex graphs.
• Deliver high-quality SAS and/or R programs for clinical development needs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Adhere to FDA regulations and good clinical practice for submissions.

Skills

Leadership

Independent work

Communication

FDA/ICH knowledge

Education

Bachelor's degree (CS/Data Science/Mathematics/Statistics)

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor-dedicated, embedded role for a global pharmaceutical client.

The role involves independently delivering high-quality programming for clinical trials, including SDTM/ADaM, define.xml, listings, and complex graphs. You will collaborate with CROs and internal teams, support regulatory submissions, and ensure compliance with FDA/ICH guidelines.