About Statistics Toolkit
Our Mission
At Statistics Toolkit, our mission is to provide exceptional statistical consulting services that empower our clients to drive assets through the pipeline to launch. We are deep subject matter experts in applying statistical methods to Discovery, Research, Analytical, Quality Control, Process Engineering, Upstream and Downstream Processing, and Commercial Manufacturing. We have extensive experience, such as ICH, WHO, etc. and in working with FDA, EMEA, Health Canada and agencies around the world. We have a proven track record of delivering convincing statistical data and analyses to address IND, NDA and BLA questions on Preclinical and CMC data. We strive to deliver customized solutions that meet the unique needs of each client.
Who we are
JoAnn Coleman
JoAnn Coleman is an accomplished consulting statistician with over 25 years of experience in Research, CMC and Manufacturing Statistics in the Pharmaceutical and Biotech Industries. JoAnn has deep expertise in the design and analysis of data for Discovery, Research, Analytical, Quality Control, Processing, and Commercial Manufacturing in a variety of modalities including, small and large molecules and AAV gene therapy. JoAnn's practical problem-solving approach has been instrumental in driving assets through the development lifecycle. She is skilled at training and enabling scientists in elementary and advanced statistical concepts and software to increase statistical capabilities of organizations. JoAnn holds an undergraduate degree in Chemistry from West Chester University and a Master's degree in Applied Statistics from Villanova University, leveraging her education to combine statistics and science throughout her career.
