Remote Principal Statistical Programmer (SAS + R)

Edition; Cape Town; Remote; ZAR 1,819,000 - 2,646,000; Full time

Job summary

Edition is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on pharmaceutical projects, reporting to the Director, Biostatistics and Programming. You will lead and mentor, oversee CRO programmers, and ensure data deliverables meet high-quality standards across studies.

The role requires extensive CDISC experience, regulatory submission support, and the ability to work independently with strong communication and leadership skills in a global context.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics major preferred
• 7+ years of experience as a Statistical Programmer on a Biotech/Pharma Clinical Development Biometrics Team or similar
• Exceptional SAS programming skills and expertise in clinical development processes
• Extensive CDISC standards experience (SDTM, ADaM, Define.xml), medical terminology, trial methodologies and FDA/ICH regulations
• Experience supporting regulatory submissions, interacting with FDA or global authorities
• Must be able to work independently
• Outstanding communication and leadership skills

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies
• Develop SAS programs which generate datasets, tables, listings and complex graphs
• Deliver high-quality SAS and/or R programming results for clinical development programs
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses
• Follow FDA regulations for reporting clinical trial data (GCP and e-submissions)
• Contribute to creation, maintenance, and validation of standards for tools, outputs, and macros
• Develop CRFs, edit check specs, and data validation plans
• Provide review/author data transfer specifications for external vendor data
• Collaborate with internal/external partners to meet project goals
• Review and/or author SOPs and Work Instructions for programming practices

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

Independent work

Communication skills

Leadership

Education

Bachelor's degree in Computer Science, Mathematics, Statistics or related

Tools

Unix/Linux

Git

Shiny

Python

Java

Markdown

Job description

Edition is seeking a Senior/Principal Statistical Programmer (SAS + R) to work remotely on pharmaceutical projects, reporting to the Director, Biostatistics and Programming. You will lead and mentor, oversee CRO programmers, and ensure data deliverables meet high-quality standards across studies.

The role requires extensive CDISC experience, regulatory submission support, and the ability to work independently with strong communication and leadership skills in a global context.