• Nancy Niemuth

    Principal Statistician

    Known as the Friendly Statistician, my consulting style is to learn about the unique situation each client faces and then apply sound statistical methods to their problem and explain clearly what I recommend. I am an expert in the statistical aspects of bioassay development, qualification, and validation. I also specialize in nonclinical efficacy evaluation of products licensed under the FDA “animal rule”.

    Through Fastrain Courses, I offer a webinars on Statistics for Potency Bioassays and Statistics for Analytical Scientists (coming in 2024). I also serve on the Scientific Committee for the Biopharmaceutical Emerging Best Practices Associations (BEBPA).

    I started a consulting practice after retiring from Battelle, an independent nonprofit scientific research organization headquartered in Columbus, OH. In my most recent role as the Technical Director of Biostatistics, I led a team of 15 statisticians and database programmers supporting Battelle’s Biomedical Research Center. I have over 25 years experience managing statistics and database support for projects in the chemical agent (nerve agents and vesicating agents), anthrax, filovirus, Sars-Cov2 (COVID) and botulinum toxin research areas. Many of the products tested were licensed under the FDA “animal rule”.

    I have written or co-authored more than 45 peer-reviewed scientific publications and presented my work at national and international meetings.

Act Two Consulting

niemuth@acttwoconsulting.com

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