Remote Senior Statistical Programmer - SAS/R for Trials

Prime Medical Casualty Group; South Africa; A distancia; ZAR 1.994.000 - 2.991.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote). You will work embedded with a pharmaceutical client, lead SAS and R programming across SDTM/ADaM, define datasets, and oversee CRO deliverables.

You will prepare study reports, regulatory submissions, and analyses, while ensuring compliance with FDA/ICH guidelines and CDISC standards. Requires 7+ years of experience, independent work, and strong communication.

Formación

• Bachelor's degree in computer science, data science, mathematics or statistics.
• 7+ years as Statistical Programmer in Biotech/Pharma or similar.
• Exceptional SAS programming skills for clinical development.
• Extensive experience with CDISC standards (SDTM/ADaM/Define.xml) and FDA/ICH regulations.
• Experience supporting regulatory submissions and interaction with regulatory authorities.
• Ability to work independently and communicate effectively.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer's guide and define.xml for multiple studies.
• Develop SAS programs to create datasets, listings, tables, and complex graphs.
• Deliver high-quality SAS/R programming outputs for clinical development programs.
• Oversee CRO programming deliverables to meet timelines and quality standards.
• Support preparation of clinical study reports, regulatory submissions, and exploratory analyses.
• Ensure compliance with FDA regulations and good clinical practice for electronic submissions.
• Create and validate standards for programming tools, outputs, and macros.
• Contribute to CRFs, edit checks, data validation plans, and data transfer specs.

Conocimientos

SAS programming

Statistical programming

CDISC SDTM/ADaM

Data analysis

Regulatory submissions

Leadership

Independence

Educación

Bachelor's degree in Computer Science/Data Science/Mathematics/Statistics

Herramientas

R

Python

Java

Shiny

Unix/Linux

git

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote). You will work embedded with a pharmaceutical client, lead SAS and R programming across SDTM/ADaM, define datasets, and oversee CRO deliverables.

You will prepare study reports, regulatory submissions, and analyses, while ensuring compliance with FDA/ICH guidelines and CDISC standards. Requires 7+ years of experience, independent work, and strong communication.