Signal Detection for Medical Scientists (PDF)

Ram C. Tiwari, Ph.D. is the Director for Division of Biostatistics, CDRH, since 2016. He joined FDA in April 2008 as Associate Director for Statistical Science and Policy in the Immediate Office, Office of Biostatistics, CDER. Prior to joining FDA, he served as Program Director and Mathematical Statistician in the Division of Cancer Control and Population Sciences at National Cancer Institute, NIH; and as Professor and Chair, Department of Mathematics, University of North Carolina at Charlotte. Dr. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics. He is a Fellow of the American Statistical Association and a past President of the International Indian Statistical Association. Dr. Tiwari has over 200 publications covering a wide range of topics using both Frequentist and Bayesian methods. His methodological work on Likelihood Ratio Test (LRT) Method for signal detection from large drug/device safety databases, Benefit-Risk Analysis, and Leveraging RWD/RWE in regulatory decision-making, has been recognized by many NCI and FDA Scientific Awards.

Dr. Jyoti Zalkikar is in the Office of Biostatistics at the Food and Drug Administration (FDA)'s Center for Drug Evaluation and Research (CDER). Her team supports the Division of Imaging and Radiation Medicine in CDER's Office of New Drugs. Dr. Zalkikar received her PhD in Mathematics (with Statistics track) from the University of California at Santa Barbara in 1988. She subsequently joined the faculty of the Department of Statistics at Florida International University in Miami, Florida, and worked there until she joined FDA/CDER in 2001. Dr. Zalkikar also served in this Division of Biostatistics in Center for Devices and Radiological Health, and Office of Science in Center for Tobacco Products during her delegations. She has published about 40 papers in the statistical/clinical literature covering areas in Bayesian statistics, Reliability