Vice President, Head of Biometrics · Galapagos · company speakers →
Debarshi is currently Global Head of Biostatistics and Data Management consisting of approximately 30 Biostatisticians, Statistical Programmers and Data Managers across two global sites in Munich, Germany and Boston, USA for a Bio-Pharmaceutical company engaged in bringing novel drugs in Oncology and Auto-immune disease to patients. With more than 11 years of experience in drug development in the pharmaceutical industry, Debarshi has extensive and proven track-record of impactful data-driven leadership in all phases of drug development and successful regulatory interactions regarding New Drug Application (NDA) and Biologics License Application (BLA) with USFDA, EMA, and PMDA. Debarshi was the Lead Statistician of a pivotal oncology study with a real-world component, which resulted in a successful FDA approval in July 2020. In the course of the path to approval, Debarshi provided strategic leadership, led multiple interactions with FDA and provided strong statistical input in regulatory aspects of the submission. Debarshi has designed Phase I-III clinical trials, with complex adaptive features, calculating optimal sample size taking advantage of advanced simulation methods. In his current role, Debarshi has been instrumental in setting up a fully functional Statistics and Data Management Department from scratch , including a CFR 21 Part 11 validated SAS programming environment for performing in-house programming.
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