Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Syneos Health, Inc.; Madrid; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A biopharmaceutical solutions organization seeks a Sr-Principal Biostatistician in Madrid to provide statistical support for clinical projects focused on diabetes and cardiovascular areas. This role involves preparing Statistical Analysis Plans, reviewing datasets, and interacting with project teams. Candidates must be able to manage multiple projects while ensuring compliance with regulations. Minimal travel may be required. Join a forward-thinking company dedicated to customer success in the biopharmaceutical industry.

Responsabilidades

• Provide end-to-end statistical support for clinical projects in diabetes and cardiovascular therapeutic areas.
• Prepare Statistical Analysis Plans (SAPs) and mock-up displays for tables, listings, and figures.
• Develop statistical aspects of the protocol and generate randomization schedules.
• Coordinate and review work of other biostatisticians and statistician programmers.
• Conduct verification and quality control of deliverables.
• Implement company objectives and propose alternative solutions.
• Serve as the biostatistics representative on project teams.
• Monitor progress on study activities against milestones.
• Provide statistical programming support as needed.
• Lead integrated analyses and attend regulatory agency meetings.

Descripción del empleo

Sr-Principal Biostatistician - Medical Affairs (Europe and LATAM ONLY)

Updated: December 4, 2025
Location: Madrid, Spain
Job ID:25103998-OTHLOC-3529-2DMAD-2DR

Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. We support biopharma companies with clinical development, medical affairs, and commercial activities across 110 countries.

Job Responsibilities

• Provide end‑to‑end statistical support for clinical projects in diabetes and cardiovascular therapeutic areas.
• Prepare Statistical Analysis Plans (SAPs) and well‑presented mock‑up displays for tables, listings, and figures.
• Develop statistical aspects of the protocol, generate randomization schedules, contribute to publications and the clinical study report.
• Coordinate and review work of other biostatisticians and statistician programmers; provide independent review of datasets, tables, listings and figures.
• Review SAS annotated CRFs, database design, and study documentation to ensure protocol criteria are met and data capture is adequate.
• Conduct verification and quality control of deliverables, ensuring output aligns with SAP and specifications.
• Implement company objectives and propose alternative solutions to operational challenges.
• Serve as the biostatistics representative on project teams and interface with other departmental representatives.
• Schedule and manage multiple projects, adapt workload to changing priorities, and communicate difficulties to management.
• Monitor progress on study activities against milestones and ensure timelines for deliverables are met.
• Provide statistical programming support as needed.
• Participate in Data Safety Monitoring Board or Data Monitoring Committee activities as an independent non‑voting biostatistician.
• Lead integrated analyses, attend regulatory agency meetings, or respond to questions to support statistical analysis results.
• Follow applicable SOPs, working instructions, and regulatory guidelines (e.g. ICH).
• Maintain well‑organized, complete, and up‑to‑date project and quality‑control documentation; ensure inspection readiness.
• Assist in business development activities: proposals, budgets and sponsor bid‑defense meetings.
• Coach and mentor other biostatistics staff.
• Perform other work‑related duties as assigned.
• Travel may be required minimally.

Additional Information

Tasks, duties, and responsibilities are not exhaustive. The Company may, at its discretion, assign other tasks, duties or responsibilities. Equivalent experience, skills, and/or education may result in differing qualifications. The Company is committed to compliance with all applicable laws, including the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations.