San Francisco Bay Area Biometrics Consulting
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San Francisco Bay Area Biometrics Consulting
Kevin Lee

Director of Data Science

Kevin Lee has been part of the pharmaceutical industry for more than 15 years with experience as a statistician, CDISC consultant, statistical programmer, and a project and industry thought leader within the clinical trial domain.  Kevin is very passionate about his profession and brings a multi-dimensional construct of expertise that he utilizes to impact the well-being of patients.  His specialties include but are not limited to:

  • FDA compliance and NDA submission preparation
  • CDISC standards development and implementation
  • End-to-end clinical trial artifacts development
  • Metadata driven process
  • MDR implementation
  • Biostatistics and statistical programming

Kevin is also a very active, data-driven solution supporter in clinical trial domains.  He is a member of the CDISC ADaM and SHARE Team, PhUSE Semantic Technology working group, and PhUSE Computational Science Symposium committee.  Kevin is a frequent speaker in the pharmaceutical industry and has presented over 40 papers at various conferences.  

Kevin earned a Master's of Science in Statistics at Villanova University following a Bachelor's of Science from the University of Pennsylvania.

Kevin is a lifetime learner who loves to network and meet new people.  He also loves football, baseball, and soccer.  His wife consistently attempts to engage him in new hobbies, such as landscaping and home improvement.  Kevin participates reluctantly.

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