Principal Biostatistician Medical Affairs (Europe Only)

Syneos Health is a fully integrated biopharmaceutical solutions organization accelerating customer success. Our Clinical Development model places the customer and patient at the center of all work, continually simplifying processes to make both Syneos Health and our partners easier to work with.

What We Offer

• Career development and progression programs
• Engaged line management and a supportive team environment
• Diverse and inclusive culture that values authentic voices and belonging
• Competitive total rewards program and peer recognition

Job Responsibilities

• Provide statistical support throughout the project lifecycle, from protocol development to Clinical Study Report (CSR) completion.
• Develop Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures.
• Prepare and review randomization schedules, publications, and other protocol‑level statistical content.
• Coordinate biostatistics and statistical programming personnel to ensure timely, high‑quality deliverables.
• Review programming specifications and datasets, ensuring alignment with the SAP and statistical objectives.
• Assess CRFs, database design, and other study documentation to confirm protocol criteria are met.
• Participate in verification and quality control of deliverables, confirming consistency with the SAP and study specifications.
• Serve as the biostatistics representative on project teams, interfacing with other departmental leaders and contributing to internal meetings.
• Manage scheduling and time constraints across multiple projects, proactively communicating challenges to biostatistics management.
• Monitor progress on study activities against agreed milestones, escalating out‑of‑scope tasks to management.
• Provide statistical programming support as needed and support Data Safety Monitoring Board and/or Data Monitoring Committee activities.
• Lead integrated analyses projects and attend regulatory agency meetings or respond to questions to support statistical analysis results on behalf of the sponsor.
• Follow applicable SOPs, WIs, and regulatory guidelines (e.g., ICH).
• Maintain organized, complete, and up‑to‑date project documentation and verification/quality control programs, ensuring inspection readiness.
• Coach and mentor other biostatistics staff and perform other duties as assigned.
• Minimal travel may be required.

Qualifications

• Ph.D., M.Sc., or B.Sc. in Biostatistics, Statistics, or a related field.
• Previous clinical trial experience within Medical Affairs or related clinical development roles.
• Strong knowledge of statistical methodology and regulatory requirements (ICH, FDA, EMA).
• Proficiency in SAS and experience with statistical programming.
• Excellent communication and interpersonal skills, with the ability to collaborate across multidisciplinary teams.
• Capability to manage multiple projects, prioritize tasks, and deliver high‑quality work on schedule.
• Ability to travel when required.
• Must be located in the UK, Ireland, Poland, Spain, Greece, Hungary, Romania, Ukraine, South Africa, Belgium, or the Netherlands.

Syneos Health is committed to compliance with the Americans with Disabilities Act and the EU Equality Directive, providing reasonable accommodations to assist employees or applicants in performing essential job functions.