Principal Statistical Programmer - SAS/R (Remote)

Agc Mining Recruitment Pty Ltd; South Africa; À distance; ZAR 900 000 - 1 500 000; Plein temps

Résumé du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely for a sponsor-dedicated pharmaceutical client. You will drive SDTM/ADaM development, complex programming, and data presentation with SAS and R, collaborating with CROs and internal teams.

The role requires 7+ years of biostatistics programming experience, strong SAS and R skills, and leadership to guide colleagues, while ensuring regulatory compliance and high-quality submissions.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma
• Exceptional SAS programming skills and CDISC SDTM/ADaM experience
• Extensive experience with FDA/ICH regulations and regulatory submissions
• Ability to work independently and lead projects and teams

Responsabilités

• Generate SDTM, ADaM specifications, datasets, and define.xmls for multiple studies
• Develop SAS programs to create datasets, listings, tables, and graphs
• Deliver high-quality results with SAS and R tailored to clinical development needs
• Oversee CROs' programming deliverables to meet timelines
• Support preparation of clinical study reports, regulatory submissions, and DSURs
• Follow FDA regulations and good clinical practice for electronic submissions
• Contribute to standards, tools, and documentation for programming
• Collaborate with CROs, vendors, and internal teams to meet project goals

Connaissances

SAS programming

R programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Communication

Formation

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

Outils

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely for a sponsor-dedicated pharmaceutical client. You will drive SDTM/ADaM development, complex programming, and data presentation with SAS and R, collaborating with CROs and internal teams.

The role requires 7+ years of biostatistics programming experience, strong SAS and R skills, and leadership to guide colleagues, while ensuring regulatory compliance and high-quality submissions.