Alexis Barnes

Head of Biostatistics

Alexis is a seasoned biostatistician and biometrics leader with approximately 17 years of experience supporting Phase I–IV clinical trials across oncology, vaccines, CNS, and rare diseases in both U.S. and European regulatory environments. She brings deep expertise in leading biostatistics, statistical programming, and data standards teams within CRO settings known for managing complex and innovative development programs.

Throughout her career, Alexis has partnered closely with sponsors to provide strategic input on study design, endpoint selection, and regulatory positioning, ensuring that statistical frameworks align with both scientific objectives and long-term development plans. Her experience spans early-phase exploratory studies through to pivotal trials, giving her a comprehensive understanding of how robust biometrics strategy underpins successful regulatory outcomes. She is particularly passionate about adaptive design methodologies and forward-thinking statistical approaches that accelerate timelines while maintaining the highest standards of data integrity and regulatory compliance.

Known for her analytical precision, collaborative leadership style, and commitment to quality, she plays a central role in delivering inspection-ready results and empowering sponsors with clear, decision-enabling insights throughout the clinical development lifecycle.

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