Principal Statistical Programmer (SAS/R) – Remote

Delaire; Stellenbosch; Remote; ZAR 1,997,000 - 2,995,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with one of our pharmaceutical clients. You will lead programming efforts, ensure data quality, and deliver robust SDTM/ADaM outputs while coordinating CRO work and regulatory submissions.

You will leverage SAS and R to develop datasets, listings, and graphics, while ensuring regulatory compliance and proactive collaboration across teams in a global setting.

Qualifications

• Bachelor's degree or equivalent in a relevant field.
• 7+ years of experience as a Statistical Programmer in biotech/pharma.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml experience.
• Experience supporting regulatory submissions with FDA/ICH.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality SAS and/or R programs for clinical development programs.
• Oversee CRO statistical programming deliverables across studies and timelines.
• Support preparation of CSRs, regulatory submissions, publications, and DSURs.
• Ensure compliance with FDA regulations and GCP for submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Collaborate with CROs, vendors, and internal teams to meet project goals.
• Provide SOPs and/WI related to statistical programming practices.

Skills

SAS programming

R programming

Python programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Education

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

Tools

Unix/Linux

Git

Shiny

Java

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely with one of our pharmaceutical clients. You will lead programming efforts, ensure data quality, and deliver robust SDTM/ADaM outputs while coordinating CRO work and regulatory submissions.

You will leverage SAS and R to develop datasets, listings, and graphics, while ensuring regulatory compliance and proactive collaboration across teams in a global setting.