Senior Statistical Programmer (Remote) – SAS + R Expert

Cytel; Islas Baleares; À distance; EUR 85 000 - 120 000; Plein temps

Résumé du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated projects within one pharmaceutical client. You will lead statistical programming efforts, ensure data quality, and deliver comprehensive SDTM/ADaM outputs and regulatory deliverables.

You will collaborate with CROs and internal teams to maintain high standards, follow FDA/GCP guidelines, and implement robust programming practices across trials.

Qualifications

• 7+ years of experience as a Statistical Programmer on biotech/pharma clinical development biometrics teams
• Exceptional SAS programming skills in a clinical development environment
• Extensive experience with CDISC standards (SDTM, ADaM, Define.xml) and regulatory guidance

Responsabilités

• Generate SDTM, ADaM specifications, datasets, reviewer\'s guides and define.xml files for multiple studies
• Develop SAS programs to generate datasets, listings, tables, and complex graphs
• Oversee CRO programmers to ensure high-quality outputs and timely delivery
• Support preparation of CSRs, regulatory submissions, publications and DSURs
• 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
• Provide data transfer specifications for external vendors
• Collaborate with CROs, vendors and development partners to meet timelines
• Draft SOPs and work instructions for statistical programming practices

Connaissances

SAS programming

Leadership

Independent work

Communication

Regulatory knowledge

Formation

Bachelor's degree in Computer Science, Data Science, Mathematics, or Statistics

Outils

SAS

R

CDISC SDTM/ADaM

Description du poste

Cytel is seeking a Senior/Principal Statistical Programmer to work remotely on sponsor-dedicated projects within one pharmaceutical client. You will lead statistical programming efforts, ensure data quality, and deliver comprehensive SDTM/ADaM outputs and regulatory deliverables.

You will collaborate with CROs and internal teams to maintain high standards, follow FDA/GCP guidelines, and implement robust programming practices across trials.