Senior Statistical Programmer - Clinical Trials Lead

Cytel; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor, delivering high-quality statistical programming for multi-study clinical development programs. You will work with SAS and CDISC standards (SDTM/ADaM) and oversee CRO programmers to ensure timely, compliant outputs.

You will support regulatory submissions and study reports in a fast-paced biopharma environment. You will collaborate with statisticians, data managers, and other stakeholders, ensuring data integrity and

Qualifications

• Bachelor's degree or higher in Computer Science, Data Science, Mathematics, or Statistics.
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Experience in oncology endpoints and analyses.
• Exceptional SAS programming skills and expertise in SDTM/ADaM/Define.xml.
• Experience supporting regulatory submissions and interacting with FDA/global authorities.
• Ability to work independently and lead teams.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and graphs.
• Deliver high-quality stats programming outputs and validate SAS/R programs.
• Oversee CRO programmers to ensure timely, compliant deliverables.
• Support preparation of study reports, regulatory submissions, publications, and exploratory analyses.
• Follow FDA/ICH guidelines for electronic submissions and QC standards.
• Contribute to standards for programming tools, outputs, and macros.
• Draft CRFs, edit checks, and data validation plans.
• Provide data transfer specs for external vendor data.
• Collaborate with CROs, vendors, and clinical development partners to meet timelines.
• Prepare SOPs and work instructions for statistical programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication skills

Oncology endpoints

Education

Bachelor's degree in Computer Science / Data Science / Mathematics / Statistics

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Principal Statistical Programmer dedicated to a sponsor, delivering high-quality statistical programming for multi-study clinical development programs. You will work with SAS and CDISC standards (SDTM/ADaM) and oversee CRO programmers to ensure timely, compliant outputs.

You will support regulatory submissions and study reports in a fast-paced biopharma environment. You will collaborate with statisticians, data managers, and other stakeholders, ensuring data integrity and