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

• Plan, execute and analyse biomarker aspects of clinical or biomarker studies, develop the Biomarker Evaluation Plan and coordinate statistical activities for each study
• 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, including mock-ups of tables, listings and figures, and review SAS annotated CRFs and database design
• Support the project from protocol to CSR, including protocol, randomization schedule and input to the clinical study report
• May act as Lead Biostatistician, lead complex or multiple projects, attend regulatory agency meetings and take part in DSMB/DMC activities
• Manage schedules across several projects, monitor milestones and escalate out-of-scope tasks
• Contribute to proposals, budgets and sponsor bid defence meetings, and keep 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