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Speaker

Dr Sandeep Menon

Vice President & Head of Early Clinical Dev., Biostatistics & Adjunct Assistant Professor

Dr. Sandeep Menon is currently the vice president and the head of early clinical development statistics at Pfizer Inc. and also holds adjunct faculty positions at Boston University, Indian Institute of Management and Tufts University School
of Medicine. He is the elected fellow of American Statistical Association - a distinct recognition limited to at most one-third of one percent of the entire membership. He is responsible for overseeing all the biostatistics activities for all the therapeutic areas within Pfizer (neurosciences, inflammation & immunology (I&I), rare diseases, cardiovascular and metabolism and oncology). Responsible for managing all the senior leaders (therapeutic area heads) from discovery through proof of concept/phase 2b studies. He is the member
of the early clinical development leadership team and global clinical leadership team at Pfizer. Sandeep has extensive experience with regulatory interactions especially with
the FDA (US Agency), EMA (European Agency) and PMDA (Japan Agency). He is internationally known for his technical expertise especially in the area of adaptive designs, personalised medicine, multi-regional trials, and small
populations and has participated in the core review of the draft version of the regulatory guidance documents. He has co-authored and co-edited books and contributed to influential papers in this area. He has taught short courses internationally and is a regularly invited speaker in academia, FDA, industry forums and business management institutes.
Before being appointed as the head of early clinical development, he was the vice president and head of Statistical Research and Consulting Center (SRCC)
– center of excellence for statistics. Sandeep has been in the industry for 15 years and prior to joining Pfizer he had been in leadership roles at Biogen Idec, responsible for overseeing
biometric vendors for his programs; and at Aptiv Solutions (Currently Acquired by ICON), he was the group head and the program lead successfully delivering multiple NDA’s and PMA’s. He is the co-author and co-editor of the books titled ‘Clinical and Statistical Considerations in Personalized Medicine,’ ‘Modern Approaches to Clinical Trials Using SAS: Classical, Adaptive, and Bayesian Methods’ and ‘Biosimilars
– Clinical Development.’ In addition, he is currently co-authoring and co-editing 3 books: ‘Clinical Trial Simulations,’ ‘Confidence Intervals in Clinical Research’ and ‘Biomarkers- potential use and pitfalls.’ He is an invited member of subgroup/biomarker identification working group sponsored by
the Society for Clinical trials, and an invited program committee member at Biopharmaceutical Applied Statistics Symposium (BASS). He is the vicechair of cross industry/FDA -Adaptive Design Scientific Working Group under DIA (Drug Information Association); invited steering committee member
for the annual FDA/Industry Statistics Forum; and is in the advisory board for the M.S. in biostatistics program at Boston University. He is serving as an associate editor of American Statistical Association (ASA) journal Statistics in Biopharmaceutical Research (SBR) and as a core selection committee member of Samuel S. Wilks Memorial Award offered by ASA.

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