Jonathan Siegel
Director Statistical Sciences Oncology @Bayer
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WORK HISTORY
Director Statistical Sciences Oncology @Bayer
Pharmaceutical Oncology Biostatistics Overall compound lead with responsibility for clinical development for three oncology compounds: anetumab ravtansine, an antibody-drug conjugate; bapotulimab, a 2nd generation immune checkpoint inhibitor; and Xofigo (Ra-223), an alpha-particle emitting calcium mimic; each at different phases in the development/lifecycle management process. Clinical plan development, strategic consulting, interactions with regulatory authorities from multiple jurisdictions, briefing document and regulatory response preparation, study design from first in human through lifecycle management, concept and protocol development, SAPs and project standards, IRB and scientific review committee interactions, study start-up activities, CSR development and review, publication authorship. Supervising project and study statisticians. Review and senior management briefings and consultation on alternatives and risks. Represent statistics at compound-related regulatory meetings and at global program teams (compound strategy governance boards), including joint program teams with co-development partners. Represented oncology statistics for cross-functional quality improvement initiatives including on-board training of new clinical leads, TransCelerate template implementation and implementation of estimands framework, immuno-oncology related standards. Member of protocol review committee for institution-initiated research. Consulted on statistics-related SOPs. Co-wrote internal guide to implementation of estimands in clinical trials.
EDUCATION
Western Michigan University
M.S., Statistics
University of Pennsylvania
B.A., Mathematics
University of Michigan
Statistics
SKILLS
ABOUT JONATHAN SIEGEL
ORCID ID: Exceptional regulatory statistical strategist…
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