Principal Consultant
Statistical Outsourcing Services
Rockville, Maryland
Mr. Walfish is Director of Global Technical Operations – Statistics for AstraZeneca. He is responsible for oversight of all statistical methods for assay transfer. Prior to AstraZeneca, Mr. Walfish was CMC Statistician at GSK, Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee. Mr. Walfish was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.
Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues. Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.
Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
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Pitfalls in Underpowered and Poorly Designed Validation Studies
Wednesday, July 24, 2024
1:35 PM – 2:05 PM CST