Principal Biostatistician - Future Roles (UK)

Principal Biostatistician at Syneos Health responsible for leading statistical analysis and mentoring biostatisticians across multiple projects, ensuring quality and compliance with regulatory standards.

Job Responsibilities

• Serve as a statistical department resource, mentor biostatisticians on job skills, oversee or develop training plans or materials, and conduct training sessions.
• Prepare Statistical Analysis Plans (SAPs), including mock‑up displays for tables, listings, and figures, and collaborate with sponsors as required.
• Handle statistical aspects of protocols, generate randomization schedules, and contribute to clinical study reports.
• Review SAS annotated CRFs, database design, and other study documentation to ensure protocol criteria are met and data is captured appropriately.
• Create or review programming specifications for analysis datasets, tables, listings, and figures.
• Direct the activities of other biostatistics personnel on assigned projects to ensure timely completion of high‑quality work and provide independent review of project work produced by other statisticians.
• Implement company objectives and devise alternative solutions to address business and operational challenges.
• Act as the biostatistics representative on project teams, interfacing with other departmental representatives, preparing for internal meetings, and contributing ideas.
• Conduct and participate in verification and quality control of project deliverables, ensuring outputs meet expected results and align with SAP and specifications.
• Manage scheduling and time constraints across multiple projects, set priorities, and communicate any difficulties with meeting timelines to biostatistics management.
• Provide statistical programming support as needed.
• Participate in Data Safety Monitoring Board (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non‑voting biostatistician, and possibly as a voting statistician.
• Lead projects involving integrated analyses, attend regulatory agency meetings, or respond to questions to support statistical analysis results of clinical trials on behalf of the sponsor.
• Provide input and reviews, and follow applicable SOPs, Work Instructions (WIs), and regulatory guidelines (e.g., ICH).
• Maintain organized, complete, and up‑to‑date project documentation, verification/quality control documents and programs, ensuring inspection readiness.
• Display willingness to work with others and assist with projects and initiatives as necessary to meet business needs.
• Prepare for internal meetings, contribute ideas, and demonstrate respect for opinions of others.
• Support business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings.
• Perform other work‑related duties as assigned.
• Travel may be required.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered, so qualifications of incumbents may differ from those listed herein. The Company will determine what constitutes an equivalent to the qualifications described above. This job description complies with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, and is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations.

Equal Opportunity Employer

We are committed to providing equal employment opportunities and fostering a diverse workforce.