Principal Statistical Programmer – SAS/R (Remote)

Kabstrading Co; KwaZulu-Natal; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel Inc. offers a fully remote Senior/Principal Statistical Programmer role focused on SAS and R within a sponsor-dedicated setting. You will generate SDTM/ADaM outputs, manage CRO contributions, and support regulatory submissions for global clinical trials.

You will implement FDA/ICH guidelines, collaborate with cross-functional teams, and help maintain programming standards and documentation.

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive CDISC SDTM/ADaM experience and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with regulatory authorities.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guides, and Define.xml for multiple studies.
• Develop SAS and R programs for datasets, listings, tables, and graphs.
• Deliver high-quality programming outputs and supervise CRO programmers.
• Support preparation of clinical study reports, regulatory submissions, and exploratory analyses.
• Contribute to standards for programming tools, outputs, and macros.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication

Education

Bachelor’s degree (CS/Data Science/Math/Statistics)

Tools

R

Python

Unix/Linux

Git

Shiny

Job description

Cytel Inc. offers a fully remote Senior/Principal Statistical Programmer role focused on SAS and R within a sponsor-dedicated setting. You will generate SDTM/ADaM outputs, manage CRO contributions, and support regulatory submissions for global clinical trials.

You will implement FDA/ICH guidelines, collaborate with cross-functional teams, and help maintain programming standards and documentation.