Remote Principal Statistical Programmer Leader

Old Mutual Life Assurance Company; Klerksdorp; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on global clinical development programs. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data summaries meet high-quality standards across studies.

The role requires extensive SAS/R expertise, CDISC standards, and experience with FDA/ICH regulations, with independence and leadership in a fast-paced environment.

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 and SDTM/ADaM expertise.
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and communicate effectively.

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 graphs.
• Deliver high-quality SAS and R programming results tailored to clinical development needs.
• Oversee CRO programmers to ensure high-quality deliverables and timelines.
• Support clinical study reports, regulatory submissions, publications and DSURs.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulations

Regulatory submissions

Leadership

Independent work

Education

Bachelor's degree in CS/DS/Math/Statistics

Tools

SAS

R

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on global clinical development programs. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data summaries meet high-quality standards across studies.

The role requires extensive SAS/R expertise, CDISC standards, and experience with FDA/ICH regulations, with independence and leadership in a fast-paced environment.