Remote Principal Statistical Programmer (SAS + R)

Moja Mzansi; South Africa; À distance; ZAR 1 983 000 - 2 975 000; Plein temps

Résumé du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on global pharmaceutical projects.

You will implement reporting and analysis activities, generate SDTM/ADaM outputs, scripts, and define.xmls, and guide CRO programmers to deliver high-quality data presentations. The role requires 7+ years in statistical programming, deep experience with SAS and CDISC standards, and ability to manage regulatory submissions with FDA/ICH awareness.

Qualifications

• 7+ years of experience as a Statistical Programmer on Biotech/Pharma clinical development biometrics teams or similar.
• Exceptional SAS programming skills and development of statistical programming procedures 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 FDA/global regulatory authorities.
• Ability to work independently and lead with strong communication and leadership skills.

Responsabilités

• Generate SDTM and ADaM specifications, datasets, reviewer’s guides, and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, listings, tables, and graphs for clinical studies.
• Deliver high-quality statistical programming outputs and validate/adapt SAS/R programs for development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, publications, and DSURs.

Connaissances

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

FDA/ICH regulations

Independent contributor

Leadership skills

Formation

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

Outils

SAS

R

Python

Git

Unix/Linux

Description du poste

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on global pharmaceutical projects.

You will implement reporting and analysis activities, generate SDTM/ADaM outputs, scripts, and define.xmls, and guide CRO programmers to deliver high-quality data presentations. The role requires 7+ years in statistical programming, deep experience with SAS and CDISC standards, and ability to manage regulatory submissions with FDA/ICH awareness.