Senior Principal Statistical Programmer - Remote (SAS/R)

Craven Cottage Cc; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Craven Cottage Cc is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely in South Africa. The role is embedded with a pharmaceutical client, delivering SDTM/ADaM specifications and complex analyses with autonomy and ownership.

You will lead programming activities, oversee CRO deliverables, support regulatory submissions, and ensure adherence to FDA/ICH guidelines, CDISC standards, and high-quality outputs across trials.

Qualifications

• Minimum bachelor's degree in computer science, data science, mathematics or statistics major preferred.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills with SDTM/ADaM Define.xml experience in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Able to work independently with strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables, and graphs.
• Deliver high-quality programming outputs; validate and maintain SAS and/or R programs.
• Oversee CROs' programming deliverables to meet timelines and quality.
• Support preparation of CSRs, regulatory submissions, publications, DSURs and exploratory analyses.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with CROs, vendors, and clinical development teams to meet project goals.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Communication skills

Education

Bachelor's degree in CS/Data Science/Math/Statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Job description

Craven Cottage Cc is seeking a Senior/Principal Statistical Programmer SAS + R to work remotely in South Africa. The role is embedded with a pharmaceutical client, delivering SDTM/ADaM specifications and complex analyses with autonomy and ownership.

You will lead programming activities, oversee CRO deliverables, support regulatory submissions, and ensure adherence to FDA/ICH guidelines, CDISC standards, and high-quality outputs across trials.