Principal Statistical Programmer – SAS + R, Remote

Mediclinic; South Africa; Remote; ZAR 1,994,000 - 2,991,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a global pharmaceutical client, supported by Cytel. You will work with autonomy on clinical development programs and oversee CRO programmers to ensure high-quality data summaries.

The ideal candidate has 7+ years of experience, expert SAS skills, CDISC (SDTM/ADaM/Define.xml) mastery, and regulatory submission experience. Strong communication and leadership are essential.

Qualifications

• A bachelor's degree in computer science, data science, mathematics, or statistics is required.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and experience in CDISC (SDTM, ADaM, Define.xml).
• Experience supporting regulatory submissions and working with FDA/ICH guidelines.
• Ability to work independently with minimal supervision.
• Strong written and verbal communication and leadership abilities.
• Experience with pharmacokinetic data or neuroscience is a plus.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files.
• Develop SAS programs to create datasets, tables, listings and graphs.
• Deliver high-quality SAS and R programs for clinical development programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support clinical study reports, regulatory submissions, publications and DSURs.
• Adhere to FDA regulations and good clinical practice for electronic submissions.
• Develop standards for programming tools, outputs, and macros.
• Contribute to CRF development, edit checks, and data validation plans.
• Coordinate with CROs, vendors and internal functions to meet project goals.
• Draft SOPs and work instructions for programming practices.

Skills

Independence

Leadership

Written and verbal communication

Regulatory knowledge

Education

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

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) for a fully remote role embedded with a global pharmaceutical client, supported by Cytel. You will work with autonomy on clinical development programs and oversee CRO programmers to ensure high-quality data summaries.

The ideal candidate has 7+ years of experience, expert SAS skills, CDISC (SDTM/ADaM/Define.xml) mastery, and regulatory submission experience. Strong communication and leadership are essential.