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Vijay Chauhan, Ph.D.
Director (Biostatistics & Statistical Programming)

Education

  1982-1985 Ph.D. (Statistics) - Mixed Model Methods
Edinburgh University, Scotland 
  1986-1987 Postdoctoral Fellow - Statistical modeling using mixed models.
Swiss Federal Institute of Technology, Zurich, Switzerland 
  1989-1990 Postdoctoral Fellow - Estimation of variance components.
McGill University, Montreal, Canada 

Statistical and SAS Experience

  • PhD in Statistics with specialization in mixed models methodology, and postdoctoral research experience. 
  • Over 25 years total statistical experience with 15 years in pharmaceutical and biotech companies, and CROs, meeting all criteria as mandated by the FDA, ICH and GCP guidelines. 
  • Experience includes over 20 years in SAS base, stats, graph modules, IML and macros. 
  • Protocol development, Writing Statistical Analysis Plans, Integrated summary of efficacy and safety (ISE/SCE, ISS/SCS).
  • Programming efficacy and safety summary tables, listing and figures. 
  • Validation of summary tables, listings, and figures.
  • Supporting DSMB, IDMC, Interim Analysis, publication.
  • Review CRFs, clinical study reports, and NDA briefing packages.  
  • Overseeing CROs work while working at Pharma and Biotech. companies 
  • Experience of over 25 NDA submissions, and responses to FDA questions.
  • Data exploration for marketing and commercial messages.  
  • Coordinating statistical, SAS programming, data management, and medical writing activities. 
  • Supporting drug development advisory board in evaluation of clinical trial results.  
  • Experience in supervising study teams of coworkers. 
  • Published over 35 articles in non-clinical and clinical statistics. 
  • Organized contributed sessions at FDA Industry Statistics Worshops (2012, 2013), and JSM. 
  • Therapeutic experience in oncology, cardiovascular, anticoagulants, CNS, anti-infective, HRT, acne vulgaris, weight loss, and anti-fungal studies. 
     

Pharmaceutical & Biotech Clients

Experience of working with J&J, Celgene, Bayer HealthCare, Pfizer, Genentech, and at major CROs where I had opportunities of working on projects of J&J, Janssen Research Foundation, Glaxo SmithKline, NIH, McNeil Consumer Healthcare, Purdue Pharma LLP, Mitsubishi, DepoMed Inc, Sumitomo Pharmaceuticals America Ltd, Sankyo-Pharma USA, Baxter Pharmaceutical Company, Knoll Pharmaceutical Company, Alfacell inc, and BioTime Inc.