Remote Principal Statistical Programmer - SAS, R, FDA-ready

Deel; Santa Cruz de Tenerife; A distancia; EUR 80.000 - 134.000; Jornada completa

Descripción de la vacante

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a leading pharmaceutical client. You will independently manage programming deliverables, oversee CRO work, and ensure SDTM/ADaM datasets and Define.xml are produced to a high standard.

This role emphasizes FDA/ICH compliance and cross-functional collaboration across global teams. The position requires 7+ years of pharma biometrics experience, exceptional SAS skills, CDISC expertise, and a proven

Formación

• 7+ years as Statistical Programmer in Biotech/Pharma clinical development
• Exceptional SAS programming skills and standards in clinical development
• Extensive CDISC SDTM/ADaM/Define.xml experience
• Regulatory submissions experience and interaction with authorities
• Ability to work independently and lead cross-functional teams
• Strong written and verbal communication skills

Responsabilidades

• Generate SDTM, ADaM specs, datasets, reviewer's guides and define.xml
• Develop SAS programs for datasets, listings, tables and graphs
• Deliver high-quality SAS/R programs tailored to programs' needs
• Oversee CRO programming deliverables to meet timelines
• Support clinical study reports, regulatory submissions and analyses
• Adhere to FDA/ICH guidance and GCP for electronic submissions
• Contribute to standards for programming tools and macros
• Develop CRFs, edit checks, and data validation plans
• Review data transfer specs for external vendor data
• Collaborate with CROs, vendors and partners to hit goals
• Draft SOPs and work instructions for statistical programming

Conocimientos

SAS programming

CDISC standards (SDTM/ADaM/Define.xml)

Statistical programming

Regulatory submissions experience

Leadership and communication

Educación

Bachelor's degree in CS/Math/Stats

Herramientas

SAS

R

Python

Git

Unix/Linux

Descripción del empleo

Cytel Inc. is seeking a Senior/Principal Statistical Programmer (Remote) to work embedded with a leading pharmaceutical client. You will independently manage programming deliverables, oversee CRO work, and ensure SDTM/ADaM datasets and Define.xml are produced to a high standard.

This role emphasizes FDA/ICH compliance and cross-functional collaboration across global teams. The position requires 7+ years of pharma biometrics experience, exceptional SAS skills, CDISC expertise, and a proven