Stephen Clarke
Director of Statistics and Cpv @Akebia Therapeutics
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WORK HISTORY
Director of Statistics and Cpv @Akebia Therapeutics
Cambridge, MA, US
Provide GRR analysis for Analytical to facilitate measurement system improvement Statistical Analysis of shelf-life data (both interim and final) to provide expiry information of multiple products Initiate CPV program allowing comparison of quality data from multiple manufacturing processes for both Drug Product and Drug Substance
EDUCATION
University of California, Davis
B.S.
Washington State University
M.S.
Oregon State University
Ph.D.
ABOUT STEPHEN CLARKE
STATISTICAL & LEAN SIX SIGMA EXPERT Highly experienced senior statistical and Lean Six Sigma executive who provides a practical data-driven approach to solving complex business problems. Developed model for predicting commodity prices in the oil and gas industry that now serves as part of its executive investment decision process. Instituted collaborative, cross functional initiatives within R&D organizations that provide optimization and efficiency improvements on a global scale. Consultant for the pharmaceutical industry on projects designed to significantly reduce response time to FDA inquiries and implementation of Lean Six Sigma programs that result in significant cost savings. PhD in genetics and a solid foundation in both the application of statistics and Lean Six Sigma processes from both an execution and training/mentoring perspective.
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