Lead Statistical Programmer (SAS + R) – Embedded

Cytel; España; Presencial; EUR 85.000 - 115.000; Jornada completa

Descripción de la vacante

Cytel seeks a Principal Statistical Programmer embedded with a pharmaceutical client. You will drive statistical programming for clinical development, mentor CRO programmers, and deliver high-quality data outputs across SDTM/ADaM, tables, and CSR support.

You will work with FDA/ICH guidelines, contribute to regulatory submissions, and help advance patient treatment innovations with autonomy and ownership.

Formación

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years as a Statistical Programmer in biotech/pharma biometrics.
• Exceptional SAS programming skills; CDISC SDTM/ADaM/Define.xml expertise.
• Experience with regulatory submissions and FDA/ICH regulations.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guides and define.xml files.
• Develop SAS programs to create datasets, tables, listings, and graphs.
• Oversee CRO programmers to ensure quality and timelines.
• Support clinical study reports, regulatory submissions, DSURs and analyses.
• Collaborate with CROs, software vendors, and clinical teams.

Conocimientos

SAS programming

R programming

CDISC SDTM/ADaM/Define.xml

FDA/ICH regulations

Independent work

Leadership

Communication skills

Educación

Bachelor’s degree in computer science or statistics

Herramientas

Python

Java

Shiny

Unix/Linux

Git

Markdown

Descripción del empleo

Cytel seeks a Principal Statistical Programmer embedded with a pharmaceutical client. You will drive statistical programming for clinical development, mentor CRO programmers, and deliver high-quality data outputs across SDTM/ADaM, tables, and CSR support.

You will work with FDA/ICH guidelines, contribute to regulatory submissions, and help advance patient treatment innovations with autonomy and ownership.