Senior Principal Statistical Programmer – Remote

More Collection; South Africa; Remote; ZAR 1,990,000 - 2,985,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role. You will work with a sponsor and Cytel support to lead statistical programming across clinical studies, ensuring SDTM/ADaM compliance and define.xml outcomes.

Candidates should have 7+ years in statistical programming, extensive CDISC experience, and track record in regulatory submissions and CRO oversight. Independence and leadership are essential for success.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics teams.
• Exceptional SAS programming skills in clinical development.
• Experience with CDISC SDTM, ADaM, and Define.xml; FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with regulators.
• Ability to work independently and lead teams; strong communication.

Responsibilities

• Generate SDTM and ADaM specifications, datasets, reviewers' guides and define.xml files.
• Develop SAS programs for datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, and analyses.
• Ensure compliance with FDA regulations and GCP for submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs, vendors, and partners to meet project goals.

Skills

SAS programming

CDISC standards

R programming

Python

FDA/ICH regulation

Regulatory submissions

Independent work

Leadership

Communication

Education

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

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role. You will work with a sponsor and Cytel support to lead statistical programming across clinical studies, ensuring SDTM/ADaM compliance and define.xml outcomes.

Candidates should have 7+ years in statistical programming, extensive CDISC experience, and track record in regulatory submissions and CRO oversight. Independence and leadership are essential for success.