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I received my PhD. in Mathematical Statistics in 1967. I joined the research community at the Stanford University School of Medicine, Division of Immunology & Rheumatology, in 1984 as head statistician directing the biostatistics consulting and analytic support of the Arthritis Rheumatism Aging Medical Information System (ARAMIS) and Multipurpose Arthritis Center (MAC) grant-related research programs. In 1993 I was appointed Associate Professor with a joint appointment in the Departments of Medicine and of Health Research & Policy, and am currently Professor of Biostatistics at Stanford University, emeritus since 2007. My contributions to the statistics literature span numerous fields, including methods of sample size estimation, efficiency and bias of estimators, research methods for kappa statistics, non-parametric classification methods and methods of assessing multi-parameter endpoints. I have over 200 peer-reviewed publications. I have been directly involved with the development of numerous criteria rules for classification of diseases and with establishing guidelines for clinical trial research and in proposing responder criteria for osteoarthritis drugs. Since 1987, I have been a consultant on an ad hoc basis to pharmaceutical and biotechnical firms, including both start-up and established companies. I have extensive experience with devices, drugs and biologics and have participated in all aspects of applying statistics to implement investigational plans; e.g.: for protocol development, design of trials, database design. I’ve been a member of the FDA Statistical Advisors Panel, the statistical member on numerous data safety monitoring boards, and frequently represent companies at meetings with the FDA