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Pharmaceuticals |
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Pharmaceuticals |
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Clinical Trials |
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National |
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Over 25 Years of Experience in Clinical Trial Analyses and Regulatory Submission Auditing in the Pharmaceuticals Industry; Clinical Trial Experience; Women’s Health; Men’s Health; Dermatology; Pain Trials, Epilepsy Trials, Post Operative Gastro Intestinal Surgical Trials, Advanced Medical Illness Clinical Trials, HIV and AIDS Clinical Trials, Oncology Clinical Trials, Pharmacokinetic and Pharmacodynamic Investigational Trials, Large Cardiovascular Clinical Trials, Psychiatric Clinical Trials and Orthopedic Surgical Trials; Time Series Analysis; Statistical Designs; Clinical Trials Design and Data Mining; Algebra; Topology; Complex Analysis; Nonlinear Time Series Analysis; De-Identification of Medical Records |
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Fellow of the Royal Statistical Society Associate Member of Sigma Xi New York Academy of Sciences Stevens Alumni Association The Society for Mathematical Biology Biometrics Society Institute of Mathematical Statistics American Statistical Association Bernoulli Society International Statistical Institute American Mathematical Society Mathematical Association of America The Society of Rheology through the American Institute of Physics |
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President, CEO and Statistical Consultant, DNP Consultants (2012-Present); Director of Biostatistics and Data Management, Clinical Development Center, SK Life Science (2010-2012); Regulatory and Statistical Consultant, Tactical Therapeutics (2010); Associate Director, Biometrics, Progenics Pharmaceuticals (2006-2010); Senior Biostatistician, Medical Affairs, Progenics Pharmaceuticals (2004-2006); Senior Manager, Worldwide Development Quality Assurance, Pfizer Pharmaceuticals (2003-2004); Manager, Global Clinical Quality Assurance and Regulatory Standards, Pfizer Pharmaceuticals (2000-2003); Project Biostatistician and Biometrics Team Leader, Biometrics Clinical Data Operations, Pfizer Pharmaceuticals (1996-2000); Senior Biostatistician, Statistical Services Clinical Data Operations, Pfizer Pharmaceuticals (1993-1996); Biostatistician, Howmedica Pfizer Hospital Products Group Clinical Research, Pfizer Pharmaceuticals (1990-1993); Research Biostatistician, Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center (1986-1990); Assistant Research Biostatistician, Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center (1986-1989); Adjunct Lecturer, Fordham University (1985-1986); Adjunct Lecturer, Hunter College of the City of New York (1984-1986) |
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PhD., Mathematics - Stevens Institute of Technology; MA, Mathematics and BA, Mathematics - Hunter College of the City University of New York |
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The Effects of Hepatic Impairment on the Pharmacokinetics of Doxazosin, Journal of Clinical Pharmacology, January 30, 2000; Testing for the Autoregressive Structure in a Time Series, PhD. Dissertation Submitted to the Faculty of the Stevens Institute of Technology, May 15, 2010; Desipramine Pharmacokinetics When Coadministered With Paroxetine or Sertraline In Extensive Metabolizers, Journal of Clinical Psychopharmacology, May 15, 1997 |
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Successful New Drug Application (NDA) filed to the Food and Drug Administration (FDA) Relestor (Methylnaltrexone for Opioid-Induced Constipation) filed March 2007. Relestor was marketed with Wyeth/Pfizer. He analyzed Relestor data in the post-operative patient population (500 subjects) and presented the results to upper management. |
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Excellence in Pharmaceutical Consulting, Worldwide Who’s Who; Elected Fellow of the Royal Statistical Society, and Associate Member of Sigma Xi, the Scientific Research Society; Rose Sacks Scholarship Award; Harold Hoey Jr. Scholarship Award |
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