Senior Principal Statistical Programmer - SAS + R (Remote)

Ab Inbev Africa; Welkom; Remote; ZAR 1,830,000 - 2,829,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on one or more global pharmaceutical client programs. You will implement reporting and analysis activities, develop SDTM/ADaM outputs, and oversee CRO programmers to ensure high-quality data summaries.

The role requires independence, leadership, and strong communication. You will contribute to the creation of standards, support regulatory submissions, and collaborate with internal and external partners to meet

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred).
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and experience in clinical development environments.
• Extensive knowledge of CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and lead initiatives.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programming results for clinical development programs.
• Oversee CRO statistical programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, and publications.
• Follow FDA regulations and guidelines for electronic submissions (GxP).
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and partners to meet project timelines.
• Prepare and review SOPs and Work Instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Communication skills

Leadership

Independent work

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work on one or more global pharmaceutical client programs. You will implement reporting and analysis activities, develop SDTM/ADaM outputs, and oversee CRO programmers to ensure high-quality data summaries.

The role requires independence, leadership, and strong communication. You will contribute to the creation of standards, support regulatory submissions, and collaborate with internal and external partners to meet