Principal Statistical Programmer - SAS & R (Remote)

Standard Bank Group; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated arrangement for a global pharmaceutical client.

The role focuses on leading programming deliverables for multiple studies and ensuring high-quality data analyses, with strong SAS/CDISC expertise and regulatory submission experience. The successful candidate will work independently, mentor CRO programmers, and contribute to study reports, DSURs and regulatory packages while adhering to

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Biostatistics teams or similar.
• Exceptional SAS programming skills for clinical development environments.
• Extensive experience with CDISC SDTM/ADaM and Define.xml; familiarity with FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and lead teams or CRO programmers.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and complex graphs.
• Deliver high-quality SAS/R programming results for clinical development programs.
• Oversee CRO programmers to ensure high-quality deliverables and timeliness.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to creation and maintenance of programming standards, tools, outputs and macros.
• Participate in developing CRFs, edit checks and data validation plans.
• Provide review/author data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project timelines and goals.
• Assist in writing SOPs and Work Instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent worker

Leadership

Education

Bachelor's degree in CS/Data Science/Statistics

Tools

SAS

R

Python

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely within a sponsor-dedicated arrangement for a global pharmaceutical client.

The role focuses on leading programming deliverables for multiple studies and ensuring high-quality data analyses, with strong SAS/CDISC expertise and regulatory submission experience. The successful candidate will work independently, mentor CRO programmers, and contribute to study reports, DSURs and regulatory packages while adhering to