Senior Statistical Programmer - SAS + R (Remote)

Badger Holdings (Pty) Ltd; South Africa; A distancia; ZAR 1.820.000 - 2.482.000; Jornada completa

Descripción de la vacante

Cytel Inc. in a sponsor-embedded role seeks a Senior/Principal Statistical Programmer proficient in SAS and R to manage complex programming tasks for global clinical trials. The role focuses on SDTM/ADaM, Define.xml, and high-quality outputs while coordinating CROs and cross-functional teams.

You will drive data analysis, reporting and submissions, ensuring regulatory compliance and timely delivery across therapeutic areas, with remote work supported.

Formación

• 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 in a clinical development environment.
• Extensive CDISC SDTM/ADaM/Define.xml knowledge and FDA/ICH regulations.
• Ability to work independently and lead project teams.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and Define.xml files.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality SAS/R outputs and oversee CRO programmers.
• Support clinical study reports, regulatory submissions and DSURs.
• Ensure compliance with GCP and FDA electronic submission guidelines.
• Collaborate with CROs, vendors and internal partners to meet timelines.

Conocimientos

SAS programming

CDISC SDTM/ADaM

Regulatory submissions

Independence / self-driven

Leadership

Communication skills

Educación

Bachelor's degree in computer science/data science/mathematics/statistics

Herramientas

R

Python

Java

Git

Unix/Linux

Shiny

Descripción del empleo

Cytel Inc. in a sponsor-embedded role seeks a Senior/Principal Statistical Programmer proficient in SAS and R to manage complex programming tasks for global clinical trials. The role focuses on SDTM/ADaM, Define.xml, and high-quality outputs while coordinating CROs and cross-functional teams.

You will drive data analysis, reporting and submissions, ensuring regulatory compliance and timely delivery across therapeutic areas, with remote work supported.