Remote Principal Statistical Programmer (SAS + R)

Onecart Pty; South Africa; À distance; ZAR 1 000 000 - 1 800 000; Plein temps

Résumé du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive statistical programming for sponsor-driven clinical programs.

You will implement reporting and analysis activities across therapeutic areas, working with CROs to ensure high-quality data outputs and regulatory-compliant submissions. You will develop SAS and R programs for datasets, listings, and graphs, while adhering to CDISC standards and FDA/ICH regulations.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics (preferred).
• 7+ years of experience as a Statistical Programmer on Biotech/Pharma Clinical Development Biometrics Team or similar.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interactions with regulatory authorities.
• Ability to work independently and provide leadership and clear communication.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewers' guides and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables, and graphs for clinical trials.
• Deliver high-quality SAS and/or R programs tailored to trial needs; validate and maintain them.
• Oversee CROs' statistical programming deliverables across studies to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans; review data transfer specifications.

Connaissances

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Leadership & communication

Independent work

FDA/ICH regulations

Formation

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

Outils

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to drive statistical programming for sponsor-driven clinical programs.

You will implement reporting and analysis activities across therapeutic areas, working with CROs to ensure high-quality data outputs and regulatory-compliant submissions. You will develop SAS and R programs for datasets, listings, and graphs, while adhering to CDISC standards and FDA/ICH regulations.