Remote Principal Statistical Programmer & Team Leader

Placements24; South Africa; Remote; ZAR 900,000 - 1,500,000; Full time

Job summary

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program with a leading pharmaceutical client. You will work autonomously on data reporting and analysis activities across SDTM/ADaM, and oversee CROs to ensure high-quality outputs.

You will develop SAS programs to generate datasets, listings, tables, and graphs, support CSR submissions, DSURs and regulatory analyses, and ensure FDA/ICH compliance. Strong independence and leadership are essential.

Qualifications

• Bachelor's degree in a quantitative field; 7+ years as Statistical Programmer in Biotech/Pharma.
• Exceptional SAS programming skills and experience with CDISC standards.
• Experience supporting regulatory submissions and interactions with authorities.
• Ability to work independently with strong communication and leadership.
• Experience overseeing CRO programmers and collaboration across teams.

Responsibilities

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml for multiple studies.
• Develop SAS programs to create datasets, complex listings, tables, and graphs.
• Deliver high-quality statistical programming results using SAS and/or R.
• Oversee CRO deliverables and ensure timelines and quality.
• Support CSR, regulatory submissions, DSURs and exploratory analyses.
• Ensure FDA/ICH compliance and GCP for electronic submissions.
• Contribute to standards, tools, macros, and documentation.
• Develop CRFs, edit checks, and data validation plans.
• Review/exchange data transfer specifications with external vendors.
• Collaborate with internal/external partners to meet project goals.
• Draft SOPs and work instructions for programming practices.

Skills

SAS programming

CDISC SDTM/ADaM/Define.xml

Regulatory submissions experience

Independent worker

Leadership & communication

Education

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

Tools

R

Python

Java

Shiny

Unix/Linux

Git

Job description

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to join a sponsor-dedicated program with a leading pharmaceutical client. You will work autonomously on data reporting and analysis activities across SDTM/ADaM, and oversee CROs to ensure high-quality outputs.

You will develop SAS programs to generate datasets, listings, tables, and graphs, support CSR submissions, DSURs and regulatory analyses, and ensure FDA/ICH compliance. Strong independence and leadership are essential.