Senior/Principal Statistical Programmer - Remote (SAS + R)

Old Mutual Limited; South Africa; Remote; ZAR 1,824,000 - 2,321,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with a sponsor-dedicated pharmaceutical client. You will lead advanced programming, develop SDTM/ADaM, and ensure quality submissions under minimal supervision.

The role requires 7+ years in biostatistics programming, CDISC standards, and strong communication and leadership. You will mentor CRO programmers and contribute to study reports and regulatory interactions, all within a fast-changing pharmaceutical

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 Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in clinical development environments.
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml) and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and demonstrate strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS and/or R programs for clinical development needs.
• Oversee CRO programmers to ensure high-quality outputs and timelines.
• Support preparation of clinical study reports, regulatory submissions, and exploratory analyses.
• Ensure compliance with FDA regulations and good clinical practice.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and cross-functional partners to meet goals.
• Review SOPs and work instructions related to programming practices.

Skills

SAS programming

Leadership

Communication skills

CDISC SDTM/ADaM/Define.xml

Regulatory submissions experience

Education

Bachelor's degree in Computer Science/Statistics/Math/Data Science

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely with a sponsor-dedicated pharmaceutical client. You will lead advanced programming, develop SDTM/ADaM, and ensure quality submissions under minimal supervision.

The role requires 7+ years in biostatistics programming, CDISC standards, and strong communication and leadership. You will mentor CRO programmers and contribute to study reports and regulatory interactions, all within a fast-changing pharmaceutical