Senior Statistical Programmer (Remote) - SAS + R

London Early Years Foundation (Leyf); East London; A distancia; ZAR 1.983.000 - 2.975.000; Jornada completa

Descripción de la vacante

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on sponsor trials. You will develop SDTM/ADaM specifications, write SAS and R programs, and create complex listings, tables, and graphs while guiding CRO programmers.

You will contribute to regulatory submissions, study reports, and exploratory analyses, ensuring FDA/ICH compliance. Requires 7+ years of programming experience, leadership, and superior communication.

Formación

• Bachelor's degree in computer science, data science, mathematics, or statistics (minimum).
• 7+ years as a Statistical Programmer in Biotech/Pharma clinical development or similar.
• Exceptional SAS programming skills in a clinical development environment.
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml).
• Experience with regulatory submissions and FDA/ICH regulations.
• Ability to work independently and lead.
• Strong written and verbal communication and leadership abilities.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files for multiple studies.
• Develop SAS programs to produce datasets, complex listings, tables, and graphs.
• Deliver high-quality programming results and maintain SAS and/or R programs.
• Oversee CRO programmers to ensure timelines and quality for multiple studies.
• Support preparation of CDRs, regulatory submissions, publications, and DSURs.

Conocimientos

SAS programming

R programming

CDISC SDTM/ADaM

Define.xml

Regulatory submissions

FDA/ICH regulation

Leadership

Communication skills

Educación

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

Herramientas

Unix/Linux

Git

Python

Java

Shiny

Markdown

Descripción del empleo

Cytel Inc. seeks a Senior/Principal Statistical Programmer to work remotely on sponsor trials. You will develop SDTM/ADaM specifications, write SAS and R programs, and create complex listings, tables, and graphs while guiding CRO programmers.

You will contribute to regulatory submissions, study reports, and exploratory analyses, ensuring FDA/ICH compliance. Requires 7+ years of programming experience, leadership, and superior communication.