Senior Statistical Programmer — Clinical Data & Submissions

CA Financial Appointments; Cape Town; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical development programs. You will implement reporting and analysis activities, oversee CRO programming, and ensure high-quality SDTM/ADaM outputs and regulatory submissions.

The candidate should have a Bachelor's in a quantitative field, 7+ years of experience, and strong SAS expertise with CDISC standards, plus familiarity with R and other tools. Independent work and leadership are essential.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills and expertise with SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions and interactions with FDA/ICH regulators.
• Ability to work independently and lead activities; strong communication and leadership skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer's guides and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs.
• Deliver high-quality programming results; validate and maintain SAS/R programs.
• Oversee CROs' programming deliverables and ensure timelines.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA regulations and 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 vendors.
• Collaborate with internal/external partners to meet project timelines.
• Create SOPs and work instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM

R programming

Regulatory submissions

Biotech/Pharma experience

Communication

Leadership

Independent work

Unix/Linux

Git

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on pharmaceutical development programs. You will implement reporting and analysis activities, oversee CRO programming, and ensure high-quality SDTM/ADaM outputs and regulatory submissions.

The candidate should have a Bachelor's in a quantitative field, 7+ years of experience, and strong SAS expertise with CDISC standards, plus familiarity with R and other tools. Independent work and leadership are essential.