Principal Statistical Programmer (Remote) – SAS & R

Premier Human Capital Corporation; South Africa; Teletrabalho; ZAR 1 000 000 - 1 400 000; Tempo integral

Resumo da oferta

Cytel Inc. seeks a Senior/Principal Statistical Programmer (Remote) to work within a pharmaceutical client program. You will implement reporting and analysis activities, develop SDTM/ADaM specs, and lead CRO programmers to ensure high-quality data outputs for regulatory submissions.

This role requires strong SAS and R expertise, CDISC standards, and experience with FDA/ICH regulations. The position offers remote work with global collaboration and an emphasis on autonomy and ownership.

Qualificações

• Bachelor's degree in a relevant field (computer science, statistics, or life sciences).
• 7+ years as a Statistical Programmer in biotech/pharma clinical development.
• Exceptional SAS programming skills and CDISC standard expertise.
• Experience with FDA/ICH regulation and regulatory submissions.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guides, and Define.xml for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R outputs for clinical development programs.
• Oversee CRO programmers to ensure timely, high-quality deliverables.
• Support clinical study reports, regulatory submissions, and exploratory analyses.
• Follow GCP and FDA electronic submission guidelines.

Conhecimentos

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

FDA/ICH regulation

Leadership

Formação académica

Bachelor's degree in computer science / statistics

Ferramentas

SAS

R

Python

Unix/Linux

Git

Descrição da oferta de emprego

Cytel Inc. seeks a Senior/Principal Statistical Programmer (Remote) to work within a pharmaceutical client program. You will implement reporting and analysis activities, develop SDTM/ADaM specs, and lead CRO programmers to ensure high-quality data outputs for regulatory submissions.

This role requires strong SAS and R expertise, CDISC standards, and experience with FDA/ICH regulations. The position offers remote work with global collaboration and an emphasis on autonomy and ownership.