Steven Walfish

About the Expert

Steven Walfish is a Principal Science & Standards Liaison in the Global Science and Standards Division at USP in Rockville, MD.  Mr. Walfish is responsible for internal statistical support and the liaison to the Statistics Expert Committee.  Prior to joining USP, Mr. Walfish was Principal Statistician at Becton Dickinson (BD) in Franklin Lakes, NJ, Statistician at GE Healthcare in Waukesha, WI and a statistical consulting company that provides statistical analysis and training to the FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD.

Steven brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting. He has been an invited lecturer at Medical Design and Manufacturing (MD&M) Events, the Institute of Validation Technology (IVT), and Advanstar conferences. He has spoken at ASQ Division and Section conferences, and is also an editorial board member for BioPharm International and a regular contributor to the magazine.

Steven is a senior member of ASQ, an ASQ Certified Quality Engineer (CQE) and the past chair of the ASQ Biomedical Division (2006-07). He holds a Bachelor’s of Arts in Statistics from the University of Buffalo, a Master’s of Science in Statistics from Rutgers University and an Executive MBA from Boston University.

10 thoughts on “Steven Walfish”

  1. Steven,

    I attended your Statistics for the Non-Statistician seminar back on September 22-23 with a couple of coworkers. We’re now trying to apply some of what we learned and are stubbing our toes a bit. What we’d like to do is compare QC data from an “ideal” lot of product to data from each subsequent lot to determine whether the two lots are significantly different from one another. We would use the result of the test to determine pass/fail status of each new lot.

    Can you recommend a test or sequence of tests that would best suit our needs? For what it’s worth, each lot consists of about 3000 units and we’re accustomed to using Excel not Minitab (don’t own a license).



  2. Hi Steve,
    We have received a statistical review of our paper submitted to the Cardiovascular Interventions, and are looking for an expert like you to help us with answers. Please let me know if you would be interested to help.
    Best Regards,

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