Statistics Collaborative - Design and analysis for biomedical research

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Alicia Toledano, Sc.D.
Vice President

Alicia Toledano, Sc.D., joined Statistics Collaborative, Inc. (SCI) in 2009. She is a member of the American Statistical Association and the Eastern North American Region of the International Biometrics Society.

Dr. Toledano began consulting in 2001, and in 2005 she became an independent statistical consultant specializing in medical imaging devices. She works with a range of small and large companies in all stages of product development, from pilot studies to pivotal trials in support of FDA Pre-Market Approval applications. Dr. Toledano has expertise in the unique issues of statistical methods for evaluating diagnostic tests, particularly methods for correlated data, which arise from multi-reader, multi-case studies of medical imaging devices. Her growing business led her to join SCI, giving her the resources to expand her services to her clients.

She was previously on the faculty of Brown University, Center for Statistical Sciences (2000-2005) and The University of Chicago, Department of Health Studies, Cancer Research Center (1993-1999). While at Brown, she served as Protocol Statistician on seven multi-center trials run by the American College of Radiology Imaging Network (ACRIN), including the National CT Colonography Trial, and as a faculty statistician on the Digital Mammography in Screening Trial. Dr. Toledano was also Acting (2003) and Deputy (2004-2005) Director of the ACRIN Biostatistics and Data Management Center. She received two Outstanding Contribution Awards from ACRIN (2002, 2003).

Dr. Toledano served as a member of the FDA Medical Device Advisory Committee’s Panel for Radiologic Devices from 1999-2003, receiving an Advisory Committee Service Award from the FDA in recognition of distinguished service at the end of her term. She has continued to serve as a consultant to additional FDA panels since 2003.

Her major areas of research are in the design and analysis of clinical trials of medical imaging devices.

She received her B.S. in Biology from Cornell University (1987) and her M.S. and Sc.D. in Biostatistics from the Harvard School of Public Health (1991, 1993). Her dissertation was titled “Generalized Estimating Equations for Repeated Ordinal Categorical Data, with Applications to Diagnostic Medicine”.