Cecilia Hale, Ph.D., is Vice President, Biometrics, at Hurley Consulting. She is a biostatistics professional with over 20 years experience in all phases of drug development. Dr. Hale has both domestic and international experience in many therapeutic areas including oncology, respiratory medicine, urology, neurology, hepatic dysfunction, endocrinology, oncology imaging, and radiopharmaceuticals. She has participated in over 20 meetings with FDA, from pre-IND through advisory committee meetings.
Dr. Hale leads Hurley Consultings biometrics group with responsibility for day-to-day work and adherence to the highest standards of statistical science. Her expertise encompass study design, protocol and statistical analysis plan preparation, data collection, analysis and reporting, and adherence to health authority guidelines and Good Clinical Practice. She is responsible for the interpretation of study results in conjunction with medical and scientific colleagues. Under her leadership, the biometrics group collaborates with the clinical group; to collect and clean clinical data using EDC, ePRO, and paper. The group also produces FDA compliant submission ready SDTM and ADaM datasets; and analyzes and reports single study and pooled study data for regulatory submission.
Before joining Hurley Consulting, Dr. Hale worked in various positions in Biostatistics at several pharmaceutical companies including Progenics Pharmaceuticals, Pfizer Consumer Healthcare, GlaxoSmithKline Consumer Healthcare, Image Solutions, Inc., Smith Hanley Consulting Group, Knoll Pharmaceutical Company, and DuPont Merck Pharmaceutical Co. In 1999 she cofounded Zurich Biostatistics, Inc. (ZBI), which she integrated into Image Solutions, Inc., in 2007 upon the sale of ZBI. She was also a research statistician and statistical consultant at Montefiore Medical Center.
Dr. Hale holds a bachelors degree in mathematics from the State University of New York at Binghamton. She also holds a graduate degree in mathematical statistics and a doctoral degree in biostatistics from Columbia University. Dr. Hale has authored or coauthored several journal articles and presented at numerous scientific meetings.