Shuangge Steven Ma, Department Chair and Professor of Biostatistics, Yale University

Dr. Shuangge Steven Ma is the President-Elect of the New England Statistical Society (NESS). He received his Ph.D. degree in statistics at the University of Wisconsin in 2004. Prior to arriving at Yale, Dr. Ma was a Senior Fellow in Collaborative Health Studies Coordinating Center (CHSCC) and Department of Biostatistics at University of Washington. He has been involved in developing novel statistical and bioinformatics methodologies for analysis of cancer (NHL, breast cancer, melanoma, lung cancer), mental disorders, and cardiovascular diseases. He has also been involved in health economics research, with special interest in health insurance in developing countries.

Xun Chen, PhD, VP, Global Head of Biostatistics & Programming, Sanofi

Xun Chen holds a PhD degree in Biostatistics from Columbia University. She is currently the Global Head of Biostatistics at Sanofi. In this role, she oversees the end to end statistical strategy and execution for all of Sanofi’s product development, which encompasses products in various therapeutic areas, such as Immunology, Rare disease, Rare Blood Disorder, Oncology, Neurology, and Diabetes etc. Xun also serves as the President of International Chinese Statistical Association this year.

John Scott, PhD, Division Director of Biostatistics, CBER, FDA

Presentation title: Innovative Statistical Approaches to Help Accelerate Rare Disease Drug Development: Bayes and Beyond

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, vaccine and drug safety, data and text mining, and benefit-risk assessment. He is the CBER lead for 21st Century Cures and PDUFA efforts in Complex and Innovative Trial Design and has been heavily involved in a number of FDA's statistical policy and outreach projects, including the 2019 Adaptive Design Guidance for Drugs and Biologics, the 2020 Guidance on Interacting with the FDA on Complex Innovative Trial Design, the ICH E9(R1) expert working group on estimands and sensitivity analyses, and the ICH E20 expert working group on adaptive designs. Dr. Scott holds a Ph.D. in Biostatistics from the University of Pittsburgh, an A.M. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and is a past Editor of the journal, Pharmaceutical Statistics.

Miganush Stepanians, PROMETRIKA

Dr. Miganush Stepanians is the President and CEO of PROMETRIKA, which she founded in 2003. Dr. Stepanians has more than 30 years of experience in drug development, with a specific focus on biostatistics and data management in the pharmaceutical industry as well as academia. In addition to overall responsibility for the company’s scientific and operational activities, Dr. Stepanians is a practicing biostatistician, directly involved in study design and analysis, strategic product development planning, and commercialization support. Dr. Stepanians has designed the analyses for the Integrated Summaries of Efficacy and Safety for more than 20 successful marketing applications (NDAs; MAAs) and has presented on behalf of sponsors in meetings with FDA. She has particular expertise in challenging study design and analysis problems, including adaptive design trials, and has participated as a voting or non-voting member of a number of Independent Data Monitoring Committees. Prior to founding PROMETRIKA, Dr. Stepanians served as Director of Biostatistics and Data Management at Muro Pharmaceutical/Viatris, Inc., which she joined in 1993. Dr. Stepanians received her Doctor of Philosophy degree in Statistics from Boston University in 1994. She received her Master of Science degree in Mathematics (Statistics) from Massachusetts Institute of Technology in 1984 and her Bachelor of Science degree in Mathematics and Psychology from Boston University in 1982.

Kelley Kidwell, Professor of Biostatistics, Associate Chair for Academic Affairs, University of Michigan

Presentation title: Advancing Rare Disease Drug Development through snSMART Design

Kelley Kidwell, Ph.D., is a Professor and Associate Chair of Academic Affairs of Biostatistics at the University of Michigan School of Public Health. She is an expert in large and small sample sequential, multiple assignment, randomized trial (SMART) design and analysis. She is the primary investigator of current FDA and PCORI contracts, also had previous FDA and PCORI methods contracts, all related to SMART design, and has been a co-investigator on many NIH and industry funded, clinical trial grants. Her current focus is on advancing small sample clinical trial design and methods and incorporating patient treatment preferences into clinical trials.

Douglas Kerr, MD/PhD/MBA, Venture Partner, Atlas Venture

Presentation title: Clinical and Statistical Considerations in ALS and SMA

Doug is a neurologist and neuroscientist with over 130 publications in medical journals many of which involved stem cell transplantation for preclinical models of neurologic disorders. He has led the development of therapies for neurologic and rare genetic diseases in the biotech industry and served on boards and scientific advisory boards of various non-profits and companies. Doug graduated from Princeton with a degree in molecular biology and completed an MD/PhD at Jefferson Medical College. After a neurology residency at Johns Hopkins, he served on its faculty for 10 years, conducting research and clinical trials. Doug then led neurodevelopmental and neurodegenerative disorder programs at Biogen. Doug was the global lead for a series of programs in Alzheimer’s disease, Amyotrophic Lateral Sclerosis (ALS) and Spinal Muscular Atrophy (SMA). Doug led the team that developed the drug Spinraza™, now approved for SMA. After Biogen, Doug ran the neurodevelopmental and neuroscience franchises at Shire. In 2017, Doug founded and joined Generation Bio-a biotech company focused on non-viral gene therapy- as the head of R&D/CSO and then the Chief Medical Officer. Currently, Doug is a Venture Partner at Atlas Venture, creating new biotech startups.

Stephen Lake, PhD, VP of Quantitative Sciences, Alexion

Presentation title: Causal inference options for a Phase 3 single-arm study with external control

Stephen Lake is the Vice President of Quantitative Sciences at Alexion, the rare disease unit of AstraZeneca. At Alexion, he leads the biostatistics, statistical programming, epidemiology and real world science, medical writing, and transparency and disclosure functions. Prior to joining Alexion, he worked at Wave Life Sciences and Clementia Pharmaceuticals and spent 15 years at Genzyme and Sanofi. He holds a doctorate degree in Biostatistics from the Harvard School of Public Health.

Lee-Jen Wei, Harvard University.

L.J. Wei is a professor of Biostatistics at Harvard University. Before joining Harvard, he was a professor at the University of Wisconsin, University of Michigan, and George Washington University. His main research interest is in clinical trial methodology, especially in design, monitoring and analysis of studies. He has developed numerous novel statistical methods which are utilized often in practice. He received the prestigious Wald Medal in 2009 from the American Statistical Association for his contribution to clinical trial methodology. He is a fellow of American Statistical Associating and Institute of Mathematical Statistics. In 2014, to honor his mentorship, Harvard School of Public Health established a Wei-family scholarship to support students studying biostatistics. His recent research area is concentrated on translational statistics, personalized medicine under the risk-benefit paradigm via biomarkers and revitalizing clinical trial methodology. He has more than 270 publications and served on numerous editorial and scientific advisory boards including data monitoring for governments and industry. L. J. Wei has extensive working experience in regulatory science for developing and evaluating new drugs/devices.

Cong Li, Takeda

Dr Cong Li is an Associate Director in Statistics and Quantitative Sciences at Takeda. Specializing in oncology disease area and with 9 years of experiences in drug development, he had led multiple clinical development programs of both early and late phases. He also has a special interest in causal inference methodologies to account for treatment switching in survival endpoints. Cong holds a PhD degree from Yale University where he did his research in novel statistical methodologies to analyze high-dimensional genomics data.

Kristine Rosenberger, Boehringer Ingelheim

Dr. Kristine Rosenberger is a Senior Clinical Data Scientist at Boehringer Ingelheim. She supports early phase rare disease indications in the therapeutic area inflammation. Additionally, she has a special interest in network meta-analysis and provides insight and expertise on matters related to evidence synthesis in inflammation across various stages of clinical development. Kristine holds a Ph.D. in Biostatistics from Florida State University where her work focused on the application of research synthesis methods in evidence-based medicine.

Sean Devlin, Memorial Sloan Kettering

Dr. Sean Devlin, Ph.D., is an Associate Attending Biostatistician in the Department of Epidemiology and Biostatistics at Memorial Sloan Kettering. He completed his graduate training at the University of Washington, Seattle. For the last ten years, he has worked on the design and analysis of clinical studies for hematologic malignancies, focused primarily on cellular therapy. In addition to this collaborative work, his methodological interests include the design of early-phase clinical trials and the evaluation of prediction models.

Bingxia Wang, Takeda

Dr. Bingxia Wang currently serves as the Senior Director of Statistics and Quantitative Sciences at the Data Science Institute at Takeda. With over 15 years of experience in drug development, specializing in oncological disease areas, she has emerged as a leading expert in the statistical design of oncology clinical trials. She has played a pivotal role in shaping regulatory submissions for high-impact oncology products. She has presented on numerous topics at statistical conferences, where she loves to share her insights and knowledge to help inform quantitative decision-making processes. She is currently leading and participating in various statistical research working groups, contributing to new methodologies for treatment switch and indirect treatment comparison for RWE/RWD generation. Bingxia holds a PhD degree in biostatistics from Boston University.

Angela Qu, Parexel

Angela Qu is the SVP of Translational Medicine and Global Head of Biomarkers and Genomic Medicine at Parexel. She has over 20 years of extensive experience working in academic research and industry R&D across drug discovery and clinical development. Throughout her career, Angela has been actively engaged in leading and applying scientific innovations to translational medicine and clinical research, authoring over 50 publications focusing on translating complex genomics and clinical data in precision medicine and accelerated therapy development. She has also served on multiple professional committees including FDA-AACR joined working group as an industry representative. At Parexel, Angela leads the global team for therapeutic strategy development, precision medicine implementation, provision of scientific and medical guidance, and consulting on partnerships across a wide range of therapeutic areas. 

Eric Baron, Servier Pharmaceuticals

Eric Baron is a Senior Biostatistician at Servier Pharmaceuticals, specializing in early-phase clinical trials. He has contributed to studies in solid tumors, hematology, and glioma. Eric earned his PhD in statistics from the University of Connecticut. His research focuses on Bayesian modeling, adaptive Bayesian clinical trial designs, methods for incorporating real-world evidence, and Bayesian model assessment.

Tianyu Sun, Moderna

Tianyu Sun is a senior manager in Real-World Evidence Analytics at Moderna. He is partnering with cross-functional groups to support the development and execution of comparative effectiveness studies, disease surveillance studies, and externally controlled trials.

Menghan Hu, Sarepta Therapeutics

Dr. Menghan Hu is Senior Manager of Biostatistics at Sarepta Therapeutics, where she supports clinical trials in the late phase and data comparison with external control studies. Menghan graduated from Brown University with a Ph.D. in Biostatistics, focusing on statistical methods for structural imaging data. Before joining Sarepta, Menghan worked at Biogen for three years leading clinical trials in early phase.

Lingyun Liu, Vertex

Dr Lingyun Liu got her Ph.D. in statistics from Northwestern University. She is currently a program lead at Vertex Pharmaceuticals. She is responsible for multiple programs ranging from preclinical to post approval lifecycle management. Prior to joining Vertex, she was a consulting statistician in the strategic consulting group at Cytel. She provided consultation to biotech and pharmaceutical companies on clinical development plan, innovative trial designs, regulatory interactions across different therapeutical areas including oncology, immuno-oncology, diabetes, CNS, infectious diseases, cardiovascular and rare disease and orphan drugs. She also provided technical inputs to the development of a few modules in the commercial software EAST, StatXact and provided training to statisticians in industry and regulatory on multiple modules including MCP, MEP, MAMS, MULTIARM, SEQUENTIAL, ADAPT, SURVADAPT. Her research interests include multiple comparison, innovative trial design, external control data borrowing, composite endpoints, and rare diseases.

Denis Rybin, Pfizer

Denis Rybin is a research statistician at Pfizer Internal Medicine and Infectious Disease group supporting non-malignant hematology rare disease programs. Before recent organizational restructuring, he was a part of the Rare Disease Research Unit supporting rare disease programs in hematology and neurology. At the Unit he also supported an ultra-rare neurological disease program – the Giant Axonal Neuropathy program – developed in collaboration with NIH, academic and patient advocacy organizations. Denis joined Pfizer in 2016 after receiving PhD in biostatistics from Boston University, where he worked since 2003 at the academic CRO. His research interests include placebo response, endpoint development and information borrowing in rare disease setting.

Chunpeng Fan, Insmed Incorporated

Chunpeng Fan is the Head of Statistical Innovation and Early Assets at Insmed Incorporated. He leads innovative strategy and methodology development and provides statistical consultation to internal stakeholders. He has published over 20 first-authored statistical articles. His research interests focus on statistical methods in designing and analyses of clinical trials. He holds a Ph.D. in statistics from the University of Wisconsin-Madison.

Quang Nguyen, Regeneron Pharmaceuticals

Quang Nguyen, PhD, is currently a Manager of Biostatistics at Regeneron Pharmaceuticals within the Scientific Insights group. He supports early phase clinical trials in the Genetic Medicines as well as exploratory data analysis projects across different therapeutic areas and indications. Previously, he received his Ph.D. from the Quantitative Biomedical Sciences program at Dartmouth College, focusing on statistical methods for understanding taxa-function relationships in human gut microbiomes.

Xiang Zhang, CSL Behring

Xiang Zhang is the Head of Medical Affairs and HTA Statistics at CSL Behring, where he leads a team of statisticians focused on generating evidence to support product launches and commercialization efforts, including HTA submissions and non-interventional studies. He also co-leads the Forum for Observational Research Excellence at CSL Behring, which offers expertise to internal stakeholders on leveraging real-world data (RWD) and real-world evidence (RWE) for clinical development, regulatory submissions, and product commercialization. Dr. Zhang's research interests center on the development and application of methodologies for real-world data analysis. He has authored or co-authored over 40 peer-reviewed publications and a book titled "Real World Health Care Data Analysis: Causal Methods and Implementation Using SAS." He holds a Ph.D. in Statistics from the University of Kentucky.

Lihua Yue, BMS

Dr. Lihua Yue is working as a Director of Biostatistics in RWE Center of Excellence at BMS, where she led several Real-World External Control Arm studies in supporting single-arm clinical trials for pre-marketing regulatory submissions. She received her PhD in Statistics from Western University in 2010, and since then she worked on various clinical trials from phase I to phase IV. Her current research interest includes RWD/RWE, dynamic borrowing, and missing data imputations.

Marie-Abele Bind, Massachusetts General Hospital (MGH)

Marie-Abele Bind is an Assistant of Investigation at the Massachusetts General Hospital (MGH) Biostatistics Center and an Assistant Professor at the Harvard Medical School. Her research interests focus on developing causal inference methods for quantifying the effects of randomized and non-randomized exposures on various outcomes and understanding the mechanisms explaining these effects. Her current research is funded by the NIH Early Independence Award program. She completed her joint PhD in Biostatistics and Environmental Health at the Harvard School of Public Health, working with Professors Joel Schwartz and Brent Coull. She then became a Ziff postdoctoral Fellow at the Harvard University Center for the Environment. In 2016, she was awarded an Early Independence Award (NIH High-Risk High-Reward research grant) and became Research Associate in the Department of Statistics. From 2017 to 2021, she became a John Harvard Distinguished Science Fellow.

Marc Buyse, ScD

Marc Buyse holds degrees in engineering from Brussels University (Belgium), in management from Cranfield University (UK), and a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He worked at the European Organization for Research and Treatment of Cancer (EORTC) in Brussels and at the Dana Farber Cancer Institute in Boston, MA. He is the founder of IDDI (International Drug Development Institute), CluePoints and One2Treat, three companies offering services and software for clinical research. He is Associate Professor of biostatistics at Hasselt University in Belgium. His recent research work focuses on developing statistical methods for patient-centric medicine.

Ting Ye, University of Washington

Dr. Ting Ye is an Assistant Professor in the Department of Biostatistics at the University of Washington. She completed her PhD in Statistics at University of Wisconsin-Madison and was a postdoctoral researcher at the Department of Statistics,