Lead Statistical Programmer (Remote) - SAS + R Expert

Valterra Platinum Limited; South Africa; Remote; ZAR 900,000 - 1,300,000; Full time

Job summary

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor, embedded in one pharmaceutical client. You will lead programming efforts across SDTM/ADaM, deliver complex listings and figures, and oversee CROs to ensure timely, high-quality outputs.

You will implement reporting and analysis activities for sponsor trials, adhere to FDA/ICH guidelines, and contribute to standards and SOPs while collaborating with cross-functional teams globally.

Qualifications

• Bachelor's degree as specified in the ad.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills in clinical development.
• Extensive experience with CDISC SDTM/ADaM and Define.xml.
• Experience supporting regulatory submissions with FDA/ICH interactions.
• Ability to work independently and communicate effectively.

Responsibilities

• Generate SDTM/ADaM specifications, datasets, and define.xml for multiple studies.
• Develop SAS programs to produce datasets, tables, figures, and listings.
• Deliver high-quality programming results; validate and maintain SAS/R programs.
• Oversee CRO programmers to ensure timelines and quality.
• Support preparation of CSRs, regulatory submissions, publications, DSURs.
• Follow FDA regulations and guidelines for electronic 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 CROs, vendors, and clinical development partners.

Skills

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Independent work

Communication skills

Education

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

Tools

SAS

R

Python

Java

Shiny

Markdown

Unix/Linux

Git

Job description

Cytel Inc. seeks a Senior/Principal Statistical Programmer (SAS + R) to work remotely with a sponsor, embedded in one pharmaceutical client. You will lead programming efforts across SDTM/ADaM, deliver complex listings and figures, and oversee CROs to ensure timely, high-quality outputs.

You will implement reporting and analysis activities for sponsor trials, adhere to FDA/ICH guidelines, and contribute to standards and SOPs while collaborating with cross-functional teams globally.