Sandeep Menon

Dr. Sandeep Menon is currently an Executive Director and Head of Biostatistics at the Bio-therapeutics Research Unit at Pfizer Inc. and Adjunct Assistant Professor of Biostatistics at Boston University. He has over 11 years’ experience in clinical research spanning from CRO, Pharmaceutical Biotech and Device industry. He has led submissions (NDA, PMA and BLA) with several interactions with the FDA (US Agency), EMEA (European Agency) and PMDA (Japanese Agency). At Pfizer, he is in charge of all of the biostatistics activities for the entire portfolio in his unit spanning from discovery through Proof of concept studies. He is a member of the global biostatistics leadership team and is responsible to oversee all biostatistical aspects spanning 4 major research units in 1) Immunology and Auto-Immune Disease, 2) Inflammation and Remodeling, 3) Rare Diseases and 4) Center of Therapeutic Innovation. Before joining Pfizer, he held positions at Biogen idec, Aptiv Solutions and was a research fellow at Harvard Clinical Research Institute. Sandeep has been teaching part-time since 9 years and has taught introductory, intermediate and advanced courses in biostatistics including adaptive designs in clinical trials. He is also a biostatistics faculty (Online) for International Society of Biopharmaceutical Sciences (http://sprmm.com/sandeep-menon/). He has taught short courses and is a regular invited speaker/panelist in academic forums and FDA/Industry conferences. His research interests are in adaptive designs and personalized medicine. He has publications in well-known biostatistics journals and recently co-authored/ co-edited book titled “Clinical and Statistical Considerations in Personalized Medicine” (published in April’ 2014). He is currently co-editing/co-authoring books on” Classical, Adaptive and Bayesian Methods in Clinical trials using SAS”, “Clinical Trial Simulations”, “Confidence Intervals” and “Biosimilars”. He is the co-chair of cross Industry DIA-sponsored sub team under Adaptive Design Scientific Working Group on the “Role of Adaptive Designs in Personalized Medicine”, member of the sub-team “Biomarker identification and analysis” sponsored by the Society for Clinical trials and is in the Editorial Board for Journal of Medical Statistics and Informatics. Sandeep received his Medical degree from University of Bangalore (formerly Karnataka University), India and later completed his Masters and PhD in Biostatistics