Statistical Applications from Clinical Trials and Personalized Medicine to Finance and Business Analytics

Jianchang Lin, Ph.D., is Principal Statistician at Takeda Pharmaceuticals, with extensive experience in oncology drug clinical development, including leading successful NDA/MAA submissions and worldwide drug approvals.  Dr. Lin’s research interests include Bayesian methodologies, survival analysis and Bayesian adaptive designs, and their application in clinical trials. Bushi Wang, Ph.D., is a biostatistician at Boehringer Ingelheim Pharmaceuticals, Inc.  He researches clinical trials across different therapeutic areas and different phases, largely focusing on late stage oncology and cardiovascular trials, supporting approval.  He is co-founder of the Multiple Comparison Procedures Society, a .U.S organization supporting the international MCP conferences. Xiaowen Hu, Ph.D., is Assistant Professor in the Department of Statistics, Colorado State University.  Her research interests include spatial analysis, time series analysis, Bayesian analysis, and statistical analysis in business and empirical finance. Kun Chen, Ph.D., is Assistant Professor in the Department of Statistics, University of Connecticut.  His research interests include multivariate analysis, dimension reduction, robust statistics, statistical computing and their broad applications in ecology, genetics, public health, and other areas of applied statistics.Ray Liu, Ph.D., is Head of the Statistical Innovation and Consultation Center at Takeda Pharmaceuticals, Inc.  His research interests include design and analysis of omics studies, integrated analysis, and text mining.

• [cutting to roughly 30 papers] 1. Generalized Confidence Interval Approach for A Statistical Decision Framework Applicable to Multipopulation Tailoring Trials 2. Multi-Regional Clinical Trials - Where we have been and where we are going 3. Composite endpoints: Some common misconceptions 4. DIA Adaptive Design Scientific Working Group Best Practices Team: Objectives and Case Studies 5. Methods for Flexible Sample-Size Design in Clinical Trials 6. Statistical Challenges in Testing Multiple Endpoints in Complex Trial Designs 7. Generalized Holm's procedure for multiple testing problem 8. Assessing Benefit and Consistency of Treatment Effect under a Discrete Random Effects Model in Multiregional Clinical Trials 9. Multiplicity Adjustment in Vaccine Efficacy Trial with Adaptive Population-Enrichment Design 10. Identification of Biomarker Signatures Using Adaptive Elastic Net 11. Design and Analysis of Multiregional Clinical Trials in Evaluation of Medical Devices: A Two-component Bayesian Approach for Targeted Regulatory Decision Making 12. Evaluation of strategies for designing Phase 2 dose finding studies 13. Bayesian Hierarchical Monotone Regression I-splines for Dose-Response Assessment and Drug-Drug Interaction Analysis 14. Continuous Safety Signal Monitoring with Blinded Data 15. Bayesian integration of in vitro biomarker data to in vivo safety assessment 16. Bayesian Path Specific Frailty Models for Multi-state Survival Data with Applications 17. Sample Size Allocation in a Dose-Ranging Trial Combined with PoC 18. A Bayesian Approach For Subgroup Analysis 19. Design Considerations in Dose Finding Studies 20. Identifying Predictive Biomarkers in A Dose-Response Study 21. A nationwide cohort study of Influenza vaccine on stroke prevention in the chronic kidney disease population 22. Multivariate Spatial Modeling on Spheres 23. Statistical Method for Change-set Analysis 24. Statistical Issues in Health Related Quality of Life research 25. Analysis of clustered longitudinal/functional data 26. Variable Selection Methods for Functional Regression Models 27. Promoting Similarity of Sparsity Structures in Integrative Analysis 28. Optimal Estimation for The Functional Cox Model 29. Bayesian Spatial Clustering Method and Its Application In Radiology 30. Bayesian Nonlinear Model Selection for Gene Regulatory Networks 31. Innovated Interaction Screening for High-Dimensional Nonlinear Classification 32. Spatial Bayesian Hierarchical Model for small area estimation of categorical data 33. Evaluate the Most Accurate Animal Model With Application to Pediatric Medulloblastoma 34. Analysis Optimization for Biomarker and Subgroup Identification 35. Statistical Methods for Analytical Comparability< 36. Design and Statistical Analysis of Multidrug Combinations in Preclinical Studies and Clinical Trials 37. Composite Kernel Machine Regression Based on Likelihood Ratio Test and its Application on Genomic Studies 38. Statistical Applications for Biosimilar Product Development 39. Correcting Ascertainment Bias in Biomarker Identification 40. Subgroup-Based Adaptive (SUBA) Designs for Multi-Arm Biomarker Trials 41. ROC-based meta analysis with individual level information 42. Optimal Marker-Adaptive Designs for Targeted Therapy Based on Imperfectly Measured Biomarkers 43. Statistical considerations for evaluating prognostic imaging biomarkers 44. Stacking survival models.- Estimation of Discrete Survival Function through the Modeling of Diagnostic Accuracy for Mismeasured Outcome Data 45. A Bivariate Copula Random-Effects Model for Length of Stay and Cost 46. Non-inferiority tests for prognostic models 47. Explained Variation in Correlated Survival Data 48. Web-based Analytics for Business Decision Making 49. Economic Movement and Mental Health: A Population-based Study 50. Hypothesis Test of Mediation Effect in Causal Mediation Model with High-dimensional Mediators