Principal Biostatistician

About the role

Syneos Health is seeking a Principal Biostatistician in Tokyo, working in a hybrid setting. The role leads projects across multiple studies or programs and acts as the primary contact with the sponsor on biostatistics matters. It provides external statistical consultancy to sponsors and serves as a departmental resource for complex statistical questions, study design and protocol development.

Key responsibilities

• Mentor biostatisticians, oversee training plans and conduct training sessions for new hires and existing staff.
• Direct the work of other biostatisticians on assigned projects, provide independent review of their work and support statistical tasks from protocol to CSR.
• Prepare or oversee Statistical Analysis Plans (SAPs), including mock-ups of tables, listings and figures, and coordinate with the sponsor if needed.
• Act as Lead Biostatistician for protocol statistical aspects, randomization schedules and input to the clinical study report; create or review programming specifications for analysis datasets.
• Review SAS annotated CRFs, database design and study documentation to ensure protocol criteria are met and data are captured correctly.
• Lead complex or multiple projects such as submissions and integrated analyses, attend regulatory agency meetings and respond to questions on behalf of the sponsor.
• Manage scheduling and time constraints across projects, monitor progress against milestones and escalate out-of-scope tasks.
• Provide statistical programming support, take part in DSMB/DMC activities (possibly as a voting statistician), and follow SOPs, WIs and regulatory guidelines such as ICH.
• Maintain complete, up-to-date project documentation and quality control records, and support business development activities such as proposals, budgets and sponsor bid defenses.

Required profile

• Graduate degree in biostatistics or a related discipline.
• Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs.
• Experience across all statistical tasks from protocol to CSR; experience with regulatory submissions preferred.
• Excellent written and verbal communication skills and fluency in English.

Required skills

• Proficiency in programming.
• Knowledge of statistical design, analysis and regulatory guidelines used in clinical research.