Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry / Statistics for Biology and Health (PDF)

and Control) Statistics Focus Group Executive Committee, ASA (American Statistical Association) and ASQ (American Society for Quality). She is a Past Chair of the ASQ Chemical and Process Industries Division. Lori also represents Merck on the Statistics Leadership Group in the IQ Consortium (International Consortium for Innovation and Quality in Pharmaceutical Development). Lori holds a M.S. in Statistics and a B.S in Mathematics, both from the University of Florida.

Jorge Quiroz is a Principal Scientist in the Research CMC Statistics group of the Biometrics and Research Decision Sciences (BARDS) department in the Merck Research Laboratories division. Jorge has rewritten articles in nonclinical and CMC areas including analytical method validations, and equivalence studies.


Leslie Sidor is the Director of Quality Analytics in R&D Quality and Compliance at Biogen where she is responsible for building R&D's Quality Management analytics program. The analytics program enables risk-based decision making through the use of statistics and provides visibility into potential issues related to quality and compliance risks across R&D. Prior to joining Biogen, she led the Global Quality Engineering team at Amgen where she drove the harmonization of statistical strategies to assess analytical comparability, product stability, process development and process monitoring for bulk drug substance from clinical to commercial manufacturing. Before joining Amgen, Leslie spent 20 years at Coors Brewing Company where she held diverse roles in Quality Engineering, Quality Assurance, Quality Control, R&D and Manufacturing. Leslie holds a MSc. in Biometrics from the University of Colorado and a BS and MSc in Biology from Wayne State University, Detroit, MI.


Kimberly Vukovinsky is Senior Director of Statistics and Head of the Pharmaceutical Sciences and Manufacturing Statistics Group for Pfizer, providing support for both small and large molecule products. Kim has co-authored several publications on statistical considerations in QbD, on large sample size lot release for content uniformity, and on general statistical methods and is currently actively contributing to the application of statistics within the 3-Stage Process Validation framework. Kim is a member of and past-chair of the AAPS CMC Statistics Expert team, a member of the IQ Consortium, and a 30-year member of both the American Statistical Association and the American Society for Quality. Kim has a BS in Business Administration and Mathematics from Trinity University and an MS in Statistics from Iowa State University.
Lanju Zhang is Director in Statistics and Head of Nonclinical Statistics Group in the department of Data and Statistical Sciences at AbbVie. He leads a group providing statistical support to preclinical studies and drug manufacturingareas. Prior to moving to AbbVie, he was in MedImmune with increasing responsibilities to support all nonclinical areas. He is active in research and has published many papers and book chapters in nonclinical and clinical areas. In particular, he edited with three other people the first statistics book dedicated to all nonclinical areas, published by Springer in February 2016.