Principal Statistical Programmer – SAS + R (Remote)

University of Fort Hare; Wes-Kaap; Remote; ZAR 1,000,000 - 1,500,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor projects for a global pharmaceutical client. You will lead SDTM/ADaM programming in SAS and R, supervise CRO deliverables, and ensure data quality for regulatory submissions.

We value independence, strong communication, and leadership. Requires 7+ years in biotech/pharma programming, a relevant degree, and CDISC expertise. This role supports clinical development across multiple therapeutic areas.

Qualifications

• Minimum bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise in clinical development environments.
• Extensive CDISC (SDTM, ADaM, Define.xml) knowledge and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently with strong leadership and communication skills.
• Nice to have experience with pharmacokinetics and other tools (R, Python, Java, Shiny, Unix/Linux, Git).

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables and graphs.
• Deliver high-quality SAS/R programs for clinical development programs.
• Oversee CRO programmers to meet timelines and quality targets.
• Support preparation of clinical study reports, regulatory submissions, publications and DSURs.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit check specs and data validation plans.
• Provide review/author data transfer specs for external vendor data.
• Collaborate with CROs, software vendors and partners to meet timelines.
• Review SOPs and Work Instructions related to statistical programming practices.

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Communication skills

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. is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor projects for a global pharmaceutical client. You will lead SDTM/ADaM programming in SAS and R, supervise CRO deliverables, and ensure data quality for regulatory submissions.

We value independence, strong communication, and leadership. Requires 7+ years in biotech/pharma programming, a relevant degree, and CDISC expertise. This role supports clinical development across multiple therapeutic areas.