Principal Biostatistician (Biomarker Analyst - EMEA and US Based)

About the role

Syneos Health is hiring a Principal Biostatistician (Biomarker Analyst) working on EMEA and US-based clinical studies. The role covers biomarker aspects of clinical studies, including genomics and devices, and acts as project biomarker statistician under the guidance of an experienced statistician.

Key responsibilities

• Develop the Biomarker Evaluation Plan and coordinate statistical activities for biomarker research and development
• Design and run advanced data analysis for genomics and biomarkers, including statistical programming and complex analysis algorithms
• Own the accuracy of the Biomarker Evaluation Report and its statistical interpretation
• Mentor biostatisticians, train new hires and provide independent review of colleagues' work
• Prepare or oversee Statistical Analysis Plans (SAPs), including mock-ups of tables, listings and figures
• Review SAS annotated CRFs, database design and study documentation, and review programming specifications
• Support the protocol, randomization schedule and clinical study report, and may act as Lead Biostatistician
• Manage schedules across multiple projects, monitor milestones and escalate out-of-scope tasks
• May lead complex projects, attend regulatory agency meetings, and take part in DSMB/DMC activities
• Contribute to proposals, budgets and sponsor bid defenses, and keep project documentation inspection-ready

Required profile

• Graduate degree in biostatistics or a related discipline
• Extensive experience in clinical trials or an equivalent mix of education and experience, with the ability to lead multiple projects
• Experience across all statistical tasks from protocol to CSR, and regulatory submission experience preferred
• Excellent written and verbal communication skills and fluent English

Required skills

• Strong knowledge of biomarker evaluation, especially in oncology and ctDNA data
• Proficiency in programming
• Knowledge of statistical design, analysis and regulatory guidelines used in clinical research