Berry Consultants employs world renowned experts in Bayesian statistics and clinical trial strategy, and strives to set the standard for innovative clinical trial design, analysis, and implementation. Meet our growing team.
Don Berry, Ph.D. / Founder & Senior Statistical Scientist
Donald Berry is Founder of Berry Consultants, LLC, and a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He was founding Chair of this department in 1999. Dr. Berry received his Ph.D. in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University. He has held endowed faculty positions at Duke University and M.D. Anderson.
Dr. Berry is a well known developer of statistical theory and methodology. He has designed and supervised the conduct of hundreds of innovative clinical trials, including Bayesian adaptive trials in cancer and other diseases. He has developed Bayesian adaptive designs that efficiently use information that accrues over the course of the trial. These trials minimize sample size while increasing the likelihood of detecting therapeutic activity. A principal focus of his research is the use of biomarkers for learning which patients benefit from which therapies, based on molecular markers and phenotype. In particular, he designed and is a co-PI of I-SPY 2 in high-risk early breast cancer, a trial that was the focus of the two lead articles with two editorials in the July 2016 NEJM. He has designed Phase 3 Bayesian adaptive platform clinical trials in glioblastoma, GBM-AGILE and pancreatic cancer.
Scott Berry, Ph.D. / President & Senior Statistical Scientist
Scott Berry is President and a Senior Statistical Scientist at Berry Consultants. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. He has led Berry Consultants to be widely regarded as the premier Bayesian consulting company in the world. Since 2000, he has been involved in the design of hundreds of Bayesian adaptive clinical trials of pharmaceuticals and medical devices and has become an opinion leader in the field of Bayesian adaptive clinical trials. Some of these trials have been groundbreaking trial designs, setting new standards for innovation and flexibility in trial design. These include the trials supporting the first fully Bayesian approval by the center for drug evaluation of the United States FDA (Pravastatin-Aspirin combination) and the statistical design for Time Magazine’s #2 Medical Breakthrough of 2007 (Veridex’s GeneSearch BLN Assay). READ MORE
Statistical & Software Team
Lindsay Berry, Ph.D. / Statistical Scientist
Lindsay Berry is a Statistical Scientist at Berry Consultants. She earned her Ph.D. in Statistical Science from Duke University in 2019. Her research interests include forecasting and time series analysis, Bayesian dynamic models, hierarchical models, high-dimensional computation, decision analysis, and statistical computing. Prior to graduate school, Lindsay received her B.S. in Mathematics from the University of Texas at Austin and completed a thesis on simulation control of seamless phase II/III clinical trials.
Nick Berry, Ph.D. / Statistical Scientist
Nick Berry is a Statistical Scientist at Berry Consultants. He completed his Ph.D. in Statistics at Iowa State University in 2019 after getting his B.S. in Applied Math at Texas A&M University. His graduate research focused on computational statistics and unsupervised learning, especially clustering. Before joining Berry Consultants, he worked in statistical forensics doing automated handwriting identification, in biostatistics analyzing gut microbiome data, and in different areas of sports statistics.
Anna Bosse, M.S. / Biostatistician
Anna L. Bosse is a Biostatistician at Berry Consultants. She earned her M.S. in Biostatistics from Virginia Commonwealth University School of Medicine (2017) and her B.S. in Mathematical Statistics from Loyola University Maryland (2015). Her master’s thesis compared variance estimators used when assessing the difference between correlated AUCs with finite samples. Prior to joining Berry Consultants, she was a Biostatistician at Statistics Collaborative, Inc. (SCI) in Washington, D.C. While at SCI, she worked with clinical trials evaluating treatments in a range of therapeutic areas, including oncology, hematology, ophthalmology, psychiatric disorders, and infectious, renal and respiratory diseases. She assisted in the preparation of safety and efficacy reports for Data Monitoring Committees (DMCs), performing statistical analyses, programming analysis datasets, generating table, listing and figure presentations, and validating SAS program code.
Amy Crawford, Ph.D. / Statistical Scientist
Amy M. Crawford is a Statistical Scientist at Berry Consultants. She earned her Ph.D. in Statistics from Iowa State University in 2020. Her doctoral research focused on developing Bayesian hierarchical models for identifying the writer of handwritten documents at the NIST Forensic Science Center of Excellence. During her time in Iowa, she also worked on developing statistical learning methods for problems with dataset shift and missingness by a known mechanism with applications in credit card fraud detection. Amy earned her B.S. in Mathematics and Statistics from North Dakota State University.
Michelle Detry, Ph.D. / Director, Adaptive Trial Execution & Senior Statistical Scientist
Michelle A. Detry is a Director, Adaptive Trial Execution & Senior Statistical Scientist for Berry Consultants with expertise in Phase I, II, and III clinical trial design and analysis/reporting in support of Data Monitoring Committees (DMCs). She received her PhD in Biometry in 2003 from the University of Texas-Houston School of Public Health. Prior to joining Berry Consultants in 2011, Dr. Detry was an Assistant Scientist in the Department of Biostatistics & Medical Informatics in the University of Wisconsin School of Medicine and Public Health. In that role, she led projects focused on the design and creation of reports prepared for independent DMCs for multicenter Phase II/III and Phase III industry sponsored clinical trials, frequently taught seminars on study design and statistical methods to postdoctoral clinical fellows, and co-developed the workshop series “Clinical Research Study Design”. Prior to her position at the University of Wisconsin, Michelle was a Principal Statistical Analyst at the University of Texas M. D. Anderson Cancer where she designed clinical trials using Bayesian methods. In addition to clinical trials, Dr. Detry has experience in the analysis of data for healthcare quality improvement, epidemiology, and basic science research.
Mark Fitzgerald, Ph.D. / Senior Statistical Scientist
Mark Fitzgerald joined Berry Consultants as a Statistical Scientist in 2013. He earned his PhD in statistics from Carnegie Mellon University in 1996, and has since worked at Los Alamos National Laboratory, University of Colorado at Denver, and Neptune and Company. He has broad experience with statistical and mathematical modeling in a wide range of scientific disciplines. He especially enjoys collaborating with other researchers, which has led to work in a variety of fields, including medicine, functional magnetic resonance imaging, physics, chemistry, ecology, manufacturing, and environmental science. His research efforts emphasize stochastic simulation, Bayesian analysis, decision analysis, and expert elicitation. He has contributed to papers across disciplines with his many collaborators, as well as serving as Associate Editor for the Journal of Computational and Graphical Statistics.
Todd Graves, Ph.D. / Senior Statistical Scientist
Todd Graves joined Berry Consultants as a Statistical Scientist in January 2012 and focuses his work on the design of adaptive clinical trials for a variety of clients. For twelve years he was a member of the Statistical Sciences group at Los Alamos National Laboratory. At Los Alamos he specialized in statistical computation, Bayesian data analysis, and reliability problems, especially combining multiple sources of information. He and his coauthors won the American Society for Quality’s 2007 Frank Wilcoxon Prize. He was a Postdoctoral Fellow of the National Institute of Statistical Sciences from 1995 through 1999 after receiving his Ph.D. in Statistics from Stanford University in 1995. He has served as Associate Editor for the Journal of Computational and Graphical Statistics.
Michael Jackson / Software Engineer
Michael Jackson is a Software Engineer for Berry Consultants. He has over thirty years of experience in software design, architecture and development. Prior to joining Berry Consultants, he worked at The University of Texas at Austin in the Petroleum Engineering and Geoservices Department as a Senior Software Developer/Analyst in the research group. For ten years prior to UT, Michael worked as an independent consultant, providing software and IT services to multiple industries. Early in his career, Michael co-owned and managed one of the largest home care provider agencies in Texas and focused his efforts on the company’s software and IT infrastructure.
Roger Lewis, M.D., Ph.D. / Senior Medical Scientist
Roger J. Lewis, MD, PhD, is the Senior Medical Scientist for Berry Consultants. He received his PhD in Biophysics in 1986 and his MD in 1987 from Stanford University. He completed clinical training in emergency medicine in 1990 and is currently a Professor at the David Geffen School of Medicine at UCLA and Chair of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s expertise centers on clinical research methodology, including adaptive and Bayesian trial design, and he participates in the design and analysis of numerous laboratory, clinical, and health services research studies. His areas of interest include adaptive and Bayesian clinical trials; platform trials; translational, clinical, health services and outcomes research; emergency department crowding and disaster preparedness, interim data analysis; the role and function of data monitoring committees; and difficulties surrounding informed consent in emergency research studies. Dr. Lewis has served as a research mentor for numerous fellows and junior faculty and frequently lectures on the topics of clinical research design and the statistical analysis of clinical trials. READ MORE
Elizabeth Lorenzi, Ph.D. / Statistical Scientist
Elizabeth Lorenzi is a Statistical Scientist for Berry Consultants. She earned her Ph.D. in Statistical Science from Duke University in May 2019. Her research focused on developing machine learning and causal inference methods for precision medicine applications. While at Duke, she collaborated on multiple research projects focusing on the following clinical problems: predicting risk of complications after surgery, assessing the effectiveness of pre-operative clinics and pre-operative calculators as methods to reduce the risk of complication after surgery, and deciding treatment decisions for Type 2 Diabetes patients from electronic health record data. Prior to her time at Duke, she completed a Masters in Statistical Science and a Bachelor of Science in Statistics and Economics from Carnegie Mellon University.
Pravin Madhavan, Ph.D. / Senior Software Engineer
Pravin Madhavan is a Senior Software Engineer for Berry Consultants, where he is responsible for the development of the UI components of FACTS (Fixed and Adaptive Clinical Trial Simulator). He earned his Ph.D and B.Sc. in Mathematics from the University of Warwick and his M.Sc. in Mathematical Modelling and Scientific Computing from the University of Oxford. His Ph.D. research focused on developing and implementing efficient computational methods for partial differential equations on complex surfaces. He has authored several papers in high impact peer reviewed journals within this field. Prior to joining Berry Consultants, he was an analyst programmer at Tessella Ltd. (an international data science, analytics and AI technology consulting services provider) and a full-stack software developer at Enable International Ltd (a software product development and trading partner collaboration solutions provider).
Joe Marion, Ph.D. / Statistical Scientist
Joe Marion is a Statistical Scientist for Berry Consultants. He earned his Ph.D. in Statistics from Duke University in 2018. His research focused on computational methods for Bayesian inference, developing theoretical guarantees for sequential Monte Carlo estimators and adaptive path selection methods for thermodynamic integration. Prior to graduate school, Joe served as an artillery officer in the US Army and received his B.S. in Mathematics from Cornell University.
Anna McGlothlin, Ph.D. / Director & Senior Statistical Scientist
Anna McGlothlin is a Director and Senior Statistical Scientist for Berry Consultants. She earned her Ph.D. in Statistics from Baylor University, with research focused on Bayesian methodology and measurement error. Prior to joining Berry Consultants, she was a Senior Research Scientist in the early phase oncology group at Eli Lilly and Company. While at Lily, she was frequently sought out by colleagues for consultation on clinical trial design, especially adaptive design.
William Meurer, M.D., M.S. / Medical & Statistical Scientist
William Meurer, M.D, M.S. is an Associate Professor of Emergency Medicine and Neurology at the University of Michigan Health System. In addition, he serves as a Medical & Statistical Scientist for Berry Consultants. He works to improve the care of patients with acute neurological disease both through his work on the acute stroke team and as a researcher. His work in the field focuses on the design of clinical trials with adaptive and flexible components. In addition, he is a principal investigator of the National Institutes of Neurological Disorders and Stroke (NINDS) Clinical Trials Methodology Course (http://neurotrials.training) and a co-investigator in the clinical coordinating center of the Strategies to Innovate Emergency Clinical Care Trials (SIREN) network – also funded by NIH). He is principal investigator of NIH funded trials that include an ED based text messaging intervention for hypertension and a cluster randomized trial to improve the care of patients with acute dizziness. He was a co-investigator on the Adaptive Designs Accelerating Promising Treatments into Trials (ADAPT-IT) project, as part of the FDA Advancing Regulatory Science initiative with NIH.
He attended college at the Ohio State University, medical school at the University of Cincinnati, residency at MetroHealth/Cleveland Clinic and then came to Michigan for his stroke fellowship in 2006. During that fellowship he received an M.S. in clinical research design and statistical analysis from the University of Michigan School of Public Health. He has authored over 80 original publications (65 original scientific papers) – journals represented include JAMA. He is a core-faculty member for the University of Michigan/St. Joseph Mercy Residency. In addition, he serves clinically both the in the Emergency Department and with the University of Michigan Stroke Team.
Tom Parke / Director of Software Solutions
Tom Parke is Director of Software Solutions for Berry Consultants. Tom’s passion and experience has been software for adaptive clinical trials. Prior to joining Berry Consultants, he was Head of Clinical Trial Solutions for Tessella Ltd. While at Tessella for nearly 20 years, he managed the development and running of the software system to support Pfizer’s ASTIN Stroke trial, and has setup multiple software systems to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants. In parallel, he managed projects to develop clinical trial simulators, first with Pfizer, then Wyeth, before acting as the expert advisor and reviewer to the joint development of FACTS with Berry Consultants. Prior to working at Tessella, he worked for Inmos, Imperial Software Technology, and Praxis on compilers, operating systems and real time control systems. He graduated with a Joint First Class Honours in Math and Computer Science from Bristol University in 1979.
Melanie Quintana, Ph.D. / Director & Senior Statistical Scientist
Melanie Quintana is a Director and Senior Statistical Scientist at Berry Consultants, where she specializes in designing Bayesian adaptive clinical trials across a wide range of therapeutic areas. Her work includes numerous examples in designing platform trials and clinical trials in rare and progressive disease with a focus on developing models of disease progression to design better and more powerful clinical trials. Before joining Berry Consultants, she earned her Ph.D. in Statistics from Duke University and went on to pursue a Postdoc in Biostatistics at The University of Southern California. While at Duke and USC, she worked closely with collaborators within multiple large studies and consortiums around the nation to develop and implement analytical strategies to assess genetic risk factors for various complex diseases. These collaborations sparked and continue to fuel her interests in developing Bayesian approaches for complex clinical questions.
Ashish Sanil, Ph.D. / Senior Statistical Scientist & Software Architect
Ashish Sanil is a Senior Statistical Scientist & Software Architect at Berry Consultants, where he is responsible for the development and packaging of the core statistical components of FACTS software. He received his Ph.D. in statistics from Carnegie Mellon University and was a postdoctoral fellow at the National Institute of Statistical Sciences. Also prior to joining Berry Consultants, he was a Quantitative Analyst at Google, Inc. and a Senior Research Biostatistician at Bristol-Myers Squibb. He has authored more than 20 papers and book chapters in the statistical literature.
Christina Saunders, Ph.D. / Statistical Scientist
Christina T. Saunders is a Statistical Scientist at Berry Consultants. She earned her Ph.D. in Biostatistics from Vanderbilt University and her B.S. in Mathematics from Baylor University. While at Vanderbilt, Christina’s doctoral research focused on methods in mediation analysis and causal inference. She collaborated with investigators in Vanderbilt’s Center for Kidney Disease, studying the relationship between acute kidney injury and ICU outcomes, and in the Department of Thoracic Surgery, studying genetic ancestry and lung cancer in African Americans. She was a predoctoral trainee on the NIH Clinical and Translational Science Grant.
Ben Saville, Ph.D. / Director & Senior Statistical Scientist
Ben Saville is a Director and Senior Statistical Scientist for Berry Consultants, where he specializes in the design of innovative Bayesian adaptive clinical trials. He works primarily with medical device companies, pharmaceutical companies, and academic investigators to solve challenging problems via Bayesian designs, many of which are reviewed by the U.S. Food and Drug Administration (FDA). He has designed Bayesian clinical trials in a variety of therapeutic areas, including cardiovascular diseases, rare and progressive diseases, infectious diseases, traumatic brain injury, respiratory and digestive disorders, and cancer. Dr. Saville is a frequent invited speaker at statistical conferences, academic seminars, and lecture series, including short courses on Bayesian adaptive clinical trial design. He earned his Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill in 2008. Prior to joining Berry Consultants in 2014, Dr. Saville was an Assistant Professor of Biostatistics at Vanderbilt University where he collaborated with medical researchers in the Department of Pediatrics and the Vanderbilt-Ingram Cancer Center, and taught biostatistics courses to both undergraduate and graduate students. Dr. Saville has authored over 80 peer-reviewed publications in the statistical and medical literature, with expertise in Bayesian hierarchical models, Bayesian adaptive platform trial designs, and nonparametric methods for randomized clinical trials.
Juliana Tolles, M.D., M.H.S. / Medical & Statistical Scientist
Juliana Tolles, M.D, M.H.S. is a Medical and Statistical Scientist for Berry Consultants. She is an Assistant Professor of Emergency Medicine at the David Geffen School of Medicine at UCLA and a core faculty member for the Harbor-UCLA Emergency Medicine residency program. Her academic research interests include emergency medical services, resuscitation medicine and trauma care. She has authored several reviews for JAMA on statistical methodology and has lectured nationally on research methodology for the Society for Academic Emergency Medicine Advanced Research Methodology Evaluation and Design (ARMED) course. She is also a co-investigator for the Strategies to Innovate Emergency Clinical Care Trials (SIREN) network Southern California site.
Dr. Tolles attended college at Harvard University and medical school at Yale University School of Medicine, where she also received a Master of Health Sciences and completed a Doris Duke Fellowship in clinical research. She completed both her residency in emergency medicine and research fellowship at Harbor-UCLA Medical Center in Los Angeles.
Kert Viele, Ph.D. / Director & Senior Statistical Scientist
Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, where he leads Berry Consultants’ research enterprise. He is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. Prior to joining Berry Consultants in 2010, he was a faculty member at the University of Kentucky, where he received the Provost’s Award for Outstanding Teaching and was an investigator for NSF and NIH funded research. He has developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia, and currently serves on several data safety monitoring boards for randomized clinical trials. A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple pharmaceutical, academic, and government organizations.
Barbara Wendelberger, Ph.D. / Statistical Scientist
Barbara Wendelberger is a Statistical Scientist at Berry Consultants. She earned her PhD in 2016 from the University of Wisconsin. Her doctoral research focused on a Variational Bayesian method for estimating neural effective connectivity networks using information from multiple imaging modalities. While at Wisconsin, Barbara collaborated extensively with other investigators and academic departments to explore statistical methodology in a variety of biomedical applications. She was a predoctoral trainee on NIH training grants administered through the Institute for Clinical and Translational Research, the Computation and Informatics in Biology and Medicine Program, and the Clinical Neuroengineering Training Program. Previously, Barbara was a member of the Genomics group at Los Alamos National Laboratory, participating in both sequencing technology and metagenomics research. Barbara received her BS (Mathematics, Biological Sciences) from the University of Notre Dame in 2010 and her MS (Statistics, Biostatistics emphasis) from the University of Wisconsin in 2013. Her research interests continue to focus on data-driven inference at the juncture between statistics, mathematics, biology, and medicine.
Finance & Operations
Shawn Andersson / Vice President, Finance & Operations
Shawn Andersson is Vice President, Finance & Operations for Berry Consultants. Shawn is responsible for overseeing business operations, strategic planning and analysis, finance, human resources, contract management, and compliance for Berry Consultants. He earned his Bachelor of Business Administration in Finance from Texas A&M University and Master of Business Administration from The University of Texas at Dallas. Prior to joining Berry Consultants in 2012, he held similar operational roles for 15 years within the semiconductor industry and higher education.
Misty Vasquez / Operations Manager
Misty Vasquez is the Operations Manager for Berry Consultants. Misty joined Berry Consultants in December 2007 and handles the overall accounting, client invoicing, accounts receivable, accounts payable, and payroll for Berry Consultants. Prior to joining Berry Consultants, she worked for Texas A&M University for 17 years. Her last position there was in the Dean’s Office of the College of Engineering where she supported the advising and recruiting programs. She also was the coordinator of the College of Agriculture and Life Sciences scholarship program for 10+ years.
Doray Sitko / Senior Project Manager
Doray Sitko is a Senior Project Manager for Berry Consultants, where she is responsible for managing new project requests, tracking existing projects, coordinating resource availability, providing project management leadership, and supporting the overall growth and success of the organization. Doray is a certified Project Management Professional (PMP) with experience in health care, education, research, and business development. She holds a Master’s of Science degree in Health Education from Virginia Tech and a Bachelor’s of Health Science degree from Towson University. Prior to joining Berry Consultants, Doray provided professional and project management services in the consulting industry where she often supported work funded by federal government agencies.