Senior Principal Statistical Programmer (Remote)

Placements24; Gauteng; À distance; ZAR 900 000 - 1 300 000; Plein temps

Résumé du poste

Cytel seeks a Senior/Principal Statistical Programmer to work remotely with a sponsor client in the pharmaceutical sector. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data summaries are delivered to high-quality standards.

The role requires a minimum of 7+ years in statistical programming, expertise in SAS and CDISC (SDTM/ADaM/Define.xml), and experience with regulatory submissions. Autonomy and leadership are essential for success.

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 biometrics teams.
• Exceptional SAS programming skills and CDISC standards expertise.
• Experience supporting regulatory submissions to FDA and global authorities.

Responsabilités

• Generate SDTM, ADaM specifications, datasets, review's guide and define.xml for multiple studies
• Develop SAS programs to produce datasets, listings, tables and complex graphs
• Deliver high-quality SAS/R programs tailored to clinical development needs
• Oversee CRO programming deliverables to meet timelines
• Support preparation of clinical study reports and regulatory submissions
• Adhere to FDA/ICH regulations and GCP for electronic submissions
• Contribute to standards for programming tools, outputs, and macros
• Collaborate with internal/external partners to meet project goals

Connaissances

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independent work

Leadership

Communication

Formation

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

Outils

R

Python

Java

Shiny

Unix/Linux

Git

Description du poste

Cytel seeks a Senior/Principal Statistical Programmer to work remotely with a sponsor client in the pharmaceutical sector. You will implement reporting and analysis activities, oversee CRO programmers, and ensure data summaries are delivered to high-quality standards.

The role requires a minimum of 7+ years in statistical programming, expertise in SAS and CDISC (SDTM/ADaM/Define.xml), and experience with regulatory submissions. Autonomy and leadership are essential for success.