Lead Statistical Programmer – Oncology (SAS/ADaM)

Elpuertodesantamaria; Jaén; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Cytel seeks a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering SDTM/ADaM datasets, tables and figures on oncology programs. You will oversee CROs, ensure quality and regulatory readiness, and contribute to programming standards and SOPs.

Requirements include a bachelor’s in a quantitative field, 7+ years’ experience, strong SAS, CDISC, and regulatory submission skills, with leadership and communication abilities.

Formación

• Bachelor’s degree in a relevant field.
• 7+ years as a Statistical Programmer in Biotech/Pharma.
• Experience with oncology endpoints and analyses.
• Strong SAS programming skills in a clinical development environment.
• Extensive CDISC SDTM/ADaM and Define.xml experience.
• Experience supporting regulatory submissions with FDA/global authorities.
• Ability to work independently with strong leadership and communication.

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality statistical programming results with validated code.
• Oversee CRO programmers to meet timelines and quality standards.
• Support preparation of clinical study reports and regulatory submissions.
• Follow FDA regulations and GCP for electronic submissions.
• Contribute to standards for programming tools, outputs, and macros.
• Develop CRFs, edit checks, and data validation plans.

Conocimientos

SAS programming

CDISC SDTM/ADaM

FDA/ICH regulations

Leadership

Communication

Educación

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

Herramientas

SAS

R

Python

Unix/Linux

Git

Define.xml

Descripción del empleo

Cytel seeks a Principal Statistical Programmer to work embedded with a pharmaceutical client, delivering SDTM/ADaM datasets, tables and figures on oncology programs. You will oversee CROs, ensure quality and regulatory readiness, and contribute to programming standards and SOPs.

Requirements include a bachelor’s in a quantitative field, 7+ years’ experience, strong SAS, CDISC, and regulatory submission skills, with leadership and communication abilities.