Principal Statistical Programmer – Clinical Data Expert

Cytel; España; Presencial; EUR 85.000 - 110.000; Jornada completa

Descripción de la vacante

Cytel is seeking a Principal Statistical Programmer embedded with a pharmaceutical client. You will work with minimal supervision, oversee CRO programmers, and drive data reporting and analysis across clinical programs.

The role requires deep SAS skills, CDISC standards expertise, and regulatory submission experience. The position reports to the Director of Biostatistics and Programming in the FSP Services unit.

Formación

• Bachelor’s degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma clinical development.
• Exceptional SAS programming skills and expertise in development and implementation of statistical programming procedures.
• Extensive experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulation.
• Experience supporting regulatory submissions and interactions with FDA/global authorities.
• Ability to work independently and strong leadership and communication skills.

Responsabilidades

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml files for multiple studies.
• Develop SAS programs to generate datasets, complex listings, tables and graphs.
• Deliver high-quality statistical programming results and maintain SAS and/or R programs.
• Oversee CROs' statistical programming deliverables for multiple studies to ensure high quality and timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR, and exploratory analyses.
• Follow FDA regulations and guidelines for electronic submissions.
• Contribute to creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros.
• Develop CRFs, edit check specifications, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal and external functions to meet project timelines and goals.
• Provide review/author SOPs and Work Instructions related to statistical programming practices.

Conocimientos

SAS programming

CDISC standards

Regulatory submissions

Independent work

Communication skills

Other tools (R, Python, Java, Shiny, D

Educación

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

7+ years of experience as Statistical Programmer in Biotech/Pharma

Herramientas

SAS

R

Python

Java

Shiny

Unix/Linux

Git

Descripción del empleo

Cytel is seeking a Principal Statistical Programmer embedded with a pharmaceutical client. You will work with minimal supervision, oversee CRO programmers, and drive data reporting and analysis across clinical programs.

The role requires deep SAS skills, CDISC standards expertise, and regulatory submission experience. The position reports to the Director of Biostatistics and Programming in the FSP Services unit.