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Executive Director and Principal Biostatistician at Tigermed US and Managing Director at Tigermed, India Pvt. Ltd. Over 33 years experience in the design, analysis and reporting of phase I-IV clinical trials across multiple therapeutic areas including neurology, oncology, rare diseases, dermatology, metabolic and endocrinology, cardiovascular, respiratory, GI, vaccines, women’s health, etc.Represent sponsors at FDA Type B pre-IND, end of phase II and pre-NDA as well as Type C meetings as an expert biostatistician. Currently serve on several DMCs. Frequent presenter at numerous conferences and author of publications in peer reviewed journals.PhD in Biostatistics, a MS in Computer Sc. from the Univ. of KY, as well as a MS in Mathematics from the Indian Institute of Technology.
Global Drug Development Experts
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Managing DirectorGlobal Drug Development ExpertsGaithersburg, Md, Us
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Managing Director, Principal BiostatisticianTigermed Jan 2016 - Present
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Managing Director, Principal BiostatisticianTigermed India Data Solutions Pvt. Ltd. Jan 2016 - PresentProvide Biostatistics, SAS & R Programming, Medical Writing, Clinical Data Management, Pharmacovigilance and other clinical trial support services in US, India, China, Korea, Taiwan and other South East Asian countries.
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Principal Biostatistician / Exec Director Business DevelopmentTigermed (Hangzhou Tigermed Consulting Co., Ltd., Macrostat) Sep 2013 - PresentProvide Business Development and serve as Principal Biostatistician at Tigermed and its affiliates including MacroStat. Expertise in Clinical Development Plans, Protocol Development, Development of Clinical Trial Endpoints, Statistical Analysis Plans, ISS, ISE, Review Analyses and write Statistical Summaries. Represent sponsors at FDA meetings as Principal Biostatistician.
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Member Board Of Directors (Immediate Past President)Indian Biomedical Association Feb 2011 - Present
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Managing DirectorGlobal Drug Development Experts Jul 2006 - PresentManaging Director
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Prinicpal ConsultantQuantum Biopharma Aug 2010 - Dec 2016Consultant to Pharmaceutical and Biotechnology Companies for Clinical Development Plans, Protocol Development, Development of Clinical Trial Endpoints, Biostatistics (Statistical Analysis Plans, ISS, ISE, Review Analyses and write Statistical Summaries), Program Management, Clinical Project Management, Clinical Trial Management, CRO-Sponsor relationship maximization, Budget Development and Management and representation of sponsors at FDA meetings as Principal Biostatistician.
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Sr. Vp Clinical ResearchMedifacts Feb 2005 - Jul 2006Headed up P&L for all Clinical Research.Managed Staff globally including in US, Europe and Asia.Responsible for all Operational and Financial performance.
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Chief Information OfficerMedifacts International 1998 - 2005
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Director It, Data Management And BiostatisticsMedifacts International (M2 World Wide) 1997 - 1998
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Director Business DevelopmentClintrials Research 1995 - 1997
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Director Data Management And BiostatisticsClintrials Research 1994 - 1995
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Asociate Director Project ManagementClintrials Research 1992 - 1994
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Project ManagerClinitrials Research Inc 1991 - 1992
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Biostatistician And Sas ProgrammerStatistical Consultants Inc 1986 - 1991
Munish Mehra Skills
Munish Mehra Education Details
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University Of KentuckyPhd In Biostatistics; M.S. In Computer Sc; Msc. In Mathematics -
Indian Institute Of Technology, KanpurStatistics
Frequently Asked Questions about Munish Mehra
What company does Munish Mehra work for?
Munish Mehra works for Global Drug Development Experts
What is Munish Mehra's role at the current company?
Munish Mehra's current role is Managing Director.
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What schools did Munish Mehra attend?
Munish Mehra attended University Of Kentucky, Indian Institute Of Technology, Kanpur.
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Munish Mehra has skills like Clinical Development, Clinical Trials, Clinical Research, Drug Development, Oncology, Biotechnology, Data Management, Pharmaceutical Industry, Clinical Data Management, Ctms, Cro, Gcp.
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