Principal Statistical Programmer – SAS & R (Remote)

Placements24; South Africa; Remote; ZAR 1,819,000 - 2,812,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) embedded with one of our pharmaceutical clients. You will work independently, lead CRO programmers, and deliver compliant data summaries for regulatory submissions.

Responsibilities include generating SDTM/ADaM specifications, developing SAS/R programs, and ensuring high-quality analyses aligned with FDA regulations. This dynamic role offers remote work with global collaboration.

Qualifications

• Bachelor's degree in computer science, data science, mathematics or statistics (preferred).
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar, with drug development experience.
• Exceptional SAS programming and SDTM/ADaM/Define.xml expertise within a clinical development environment.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and complex graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CROs' programming deliverables to meet timelines.
• Assist in preparation of clinical study reports, regulatory submissions, and exploratory analyses.
• Adhere to FDA regulations, GCP, and eSub guidelines for 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 internal teams to meet project goals.
• Provide SOPs and Work Instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

R programming

Leadership

Independent work

Communication skills

Education

Bachelor's degree in computer science, data science, mathematics or statistics

Tools

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer SAS + R (Remote) embedded with one of our pharmaceutical clients. You will work independently, lead CRO programmers, and deliver compliant data summaries for regulatory submissions.

Responsibilities include generating SDTM/ADaM specifications, developing SAS/R programs, and ensuring high-quality analyses aligned with FDA regulations. This dynamic role offers remote work with global collaboration.