Principal Statistical Programmer (SAS + R) — Remote

Old Mutual South Africa; South Africa; Remote; ZAR 1,000,000 - 1,400,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program supporting a global pharmaceutical client. The role leads programming activities, oversees CROs, and delivers high-quality SDTM/ADaM outputs.

You will develop SAS and R programs, ensure FDA/GxP compliance, and participate in regulatory submissions, DSURs, and data transfers with external vendors.

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 clinical development experience.
• Extensive CDISC (SDTM, ADaM, Define.xml) and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver SAS/R programming outputs tailored to clinical programs and maintain quality.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support preparation of clinical study reports, regulatory submissions, DSURs, and analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specs, and data validation plans.
• Provide review/author data transfer specs for external vendor data.
• Collaborate with CROs, vendors, and development partners to meet goals.
• Prepare SOPs/Work Instructions related to statistical programming.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Independent work

Leadership

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program supporting a global pharmaceutical client. The role leads programming activities, oversees CROs, and delivers high-quality SDTM/ADaM outputs.

You will develop SAS and R programs, ensure FDA/GxP compliance, and participate in regulatory submissions, DSURs, and data transfers with external vendors.