Lead Principal Statistical Programmer (SAS + R) – Remote

North-West University / Noordwes-Universiteit; Noordwes; Remote; ZAR 1,498,000 - 2,496,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a global pharmaceutical client. The role focuses on SDTM/ADaM development, regulatory submissions, and CRO oversight, with leadership responsibilities and independent work under GxP guidelines.

You will deliver SAS programs for datasets, listings, and tables, develop Define.xml, and ensure high-quality data deliverables across studies, while collaborating with vendors and internal teams.

Qualifications

• Bachelor's degree in CS, data science, math, or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma development.
• Exceptional SAS programming skills for clinical development.
• Extensive CDISC (SDTM/ADaM/Define.xml) experience and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and FDA interactions.
• Ability to work independently.
• Strong written and verbal communication and leadership.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, reviewers' guide, and define.xml.
• Develop SAS programs for datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CRO programming deliverables across multiple studies to meet timelines.
• Support clinical study reports, regulatory submissions, publications, and DSURs.
• Adhere to GCP and FDA electronic submission guidelines.
• Contribute to programming standards, CRFs, edit checks, and data validation plans.
• Collaborate with CROs, vendors, and development partners to meet project goals.

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions

Independent work

Leadership

R or Python (beyond SAS)

Education

Bachelor’s degree in computer science/data science/mathematics/statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely for a global pharmaceutical client. The role focuses on SDTM/ADaM development, regulatory submissions, and CRO oversight, with leadership responsibilities and independent work under GxP guidelines.

You will deliver SAS programs for datasets, listings, and tables, develop Define.xml, and ensure high-quality data deliverables across studies, while collaborating with vendors and internal teams.