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About the speaker: As a statistician, I worked in academia, federal government, and Biotechnology/Pharma industry. I am visiting adjunct professor at the Mathematics department, IIT, Bombay, currently, teaching a graduate elective course on Epidemiology.

I was in the leadership and supervisory positions in the US government (Department of Biostatistics at Center for Drug Development and Research, Food and Drug Administration), and in the pharma industry at Johnson & Johnson (large pharma), Amgen (mid-size pharma when I began there) and Esperion (a small biotech).

Early years of my career (about 10 years) was in academic positions starting as a lecturer at Bombay University followed by several years at University of California, Santa Barbara with a brief sojourn to IIT, Mumbai. I continued methodological research and publishing during my time in the government and industry as well.

Currently, I offer statistical and regulatory consulting services to pharmaceutical companies specializing in strategic and secondary review of submission modules, DMC statistical membership, strategic reviews of protocols, statistical analysis plans mostly in dermatology, immunology, cardiovascular and antiviral therapeutic areas. I maintain a keen research interest in Statistics of Health Sciences, particularly, statistical issues related to drug approval process, causal inference, clinical trials, statistics in epidemiology, observational studies and real-world evidence paradigm based on real-world data.

I am an elected Fellow of the American Statistical Association. I have been on the editorial board of Journal of Biopharmaceutical Statistics for several years.