Principal Statistical Programmer (SAS/R) — Remote

London Early Years Foundation; East London; Remote; ZAR 1,983,000 - 2,975,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead analytic programming across trials for a major pharmaceutical client. You will independently drive SDTM/ADaM deliverables, develop SAS and R code, and oversee CRO workstreams to ensure high-quality outputs and timely submissions.

You will implement standards for programming tools, contribute to reports and regulatory submissions, and maintain alignment with FDA/ICH guidelines while collaborating with internal and

Qualifications

• Bachelor’s degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma clinical development biometrics.
• Exceptional SAS programming skills and clinical development experience.
• CDISC SDTM/ADaM, Define.xml; knowledge of FDA/ICH regulations.
• Experience supporting regulatory submissions; able to work independently.
• Strong communication and leadership abilities.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml.
• Develop SAS programs for datasets, listings, tables and graphs.
• Deliver high-quality SAS/R outputs tailored to development programs.
• Oversee CRO programmers to meet timelines and quality standards.
• Support clinical study reports, regulatory submissions and DSURs.
• Ensure compliance with FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools and macros.
• Develop CRFs, edit checks, and data validation plans.
• Review data transfer specs for external vendors.
• Collaborate with CROs, vendors and clinical development partners.
• Review SOPs and Work Instructions related to statistical programming.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership

Communication

Education

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

Tools

Python

Java

Unix/Linux

Git

Shiny

Markdown

Job description

Cytel is seeking a Senior/Principal Statistical Programmer (Remote) to lead analytic programming across trials for a major pharmaceutical client. You will independently drive SDTM/ADaM deliverables, develop SAS and R code, and oversee CRO workstreams to ensure high-quality outputs and timely submissions.

You will implement standards for programming tools, contribute to reports and regulatory submissions, and maintain alignment with FDA/ICH guidelines while collaborating with internal and