Dr. Rafia Bhore is a Biostatistician with practical experience in clinical trial designs and data analysis while working in the government and company settings. She has worked as a Senior Statistical Reviewer at the FDA for 7 years where she has reviewed over 250 clinical study protocols and reviewed approvals of over 20 new drug applications. Prior to that she has worked in the industry setting for 4 years and lead drug development clinical trial projects as a Statistician in a pharmaceutical company. Dr. Bhore has extensive experience in designing and analyzing data of clinical studies in early to late Phase 2, Phase 3 and Phase 4 stages of development. She also has experience in developing statistical analysis plans, analyzing data, and writing clinical study reports. Dr. Bhore is skilled in providing statistical support to Non-Statistician scientist colleagues and works in a collaborative and collegial manner.
RESEARCH INTERESTS
Design and Analysis of Clinical Trials (expertise in FDA Investigational New Drug [IND] applications)
Clinical Trial Designs in Infectious Diseases (expertise in HIV, Special Pathogen and Transplant drugs)
Survival Analysis, Analysis of Nonconstant Hazard
Interim Analysis Methods for Multiple Endpoints
Sensitivity Analyses
RECENT PUBLICATIONS
Bhore, R. and Gardner, S., "Analyzing Change in Hazard for Time-to-Event Endpoints in Clinical Trials" 2006 Proceedings of the American Statistical Association, Biopharmaceutical Section [CD-ROM], Alexandria, VA: American Statistical Association, 2006
Hammerstrom, T. and Bhore, R., "Testing for Change Points in Waiting Time Distributions" 2006 Proceedings of the American Statistical Association, Biopharmaceutical Section [CD-ROM], Alexandria, VA: American Statistical Association, 2006
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