Senior Principal Statistical Programmer — Remote

Mediclinic International; Welkom; Remote; ZAR 2,163,000 - 2,829,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote, sponsor-dedicated role with global pharma clients. You will lead SAS and R programming for SDTM/ADaM in clinical trials, oversee CRO work, and support regulatory submissions to ensure high-quality data delivery.

The role reports to the Director of Biostatistics and Programming within the FSP Services unit and requires independent work, strong communication, and leadership skills.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics or related field.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical biometrics.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC SDTM/ADaM and Define.xml experience.
• Experience with regulatory submissions and FDA/ICH interaction.
• Ability to work independently with strong communication and leadership.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for studies.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality statistical programming outputs and validate programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions and publications.
• Adhere to FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and SOPs.
• Collaborate with CROs, vendors and development partners to meet goals.

Skills

SAS

R

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Education

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

Tools

SAS

R

Python

Unix/Linux

git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer for a remote, sponsor-dedicated role with global pharma clients. You will lead SAS and R programming for SDTM/ADaM in clinical trials, oversee CRO work, and support regulatory submissions to ensure high-quality data delivery.

The role reports to the Director of Biostatistics and Programming within the FSP Services unit and requires independent work, strong communication, and leadership skills.