Past Award Winners

Past Award Winners

RIW:   Best Poster  Student Travel
JSM:  Best Paper   Best Poster   Best Student Paper
NCB:  Best Paper

Scholarship Award

  • Larry Han, Harvard University
  • Sasha Kravets, University of Illinois at Chicago
  • Lianlian Du, University of Wisconsin
  • Chenqi Fu, Pennsyvlania State University


  • Siddhesh Kulkarni, University of Louisville
  • Ruizhe Chen, University of Illinois at Chicago
  • Michael Lucagbo, University of Maryland
  • Inkoo Lee, Florida State University
  • Mian Arif Shams Adnan, Bowling Green State University
  • Bryan Blette (UNC, Chapel Hill)
  • Yan Gao (Univ Illinois, Chicago)
  • Yunasa Olufadi (Univ Memphis)
  • Liwen Wu (Univ Pittsburgh)
  • Xiao Wu (Harvard)
  • Busola Ololade Sanusi, UNC-Chapel Hill
  • Laura Elizabeth (Beth) Wiener, UNC-Chapel Hill
  • Nina Zhou, University of Michigan Ann Arbor
  • Christopher R. Barbour, Montana State University
  • Thevaa Chandereng, University of Wisconsin at Madison
  • Will A. Eagan, Purdue University

Best Poster Award at Regulatory-Industry Statistics Workshop
2018  2017

    Student Travel Award for Regulatory-Industry Statistics Workshop
    • Zhaohu (Jonathan) Fan, University of Cincinnati Lidner College of Business
    • Rupam Bhattacharyya, University of Michigan
    • Michael Daniel Cid Lucagbo, University of Maryland, Baltimore County
    • Thevaa Chandereng, University of Wisconsin
    • Jinyi Zhou, Duke University
    • Ariel Chernofsky, Boston University School of Public Health
    • Peifeng Ruan, The George Washington University
    • Steve B. Ampah, University of Alabama at Birmingham
    • Song Zhai, University of California, Riverside
    • Meizi Liu, University of Chicago
    • Juhyun Kim, University of California, Los Angeles
    • Jinyuan Liu, University of California, San Diego
    • Xiao Wu, Harvard University
    • Weiji Su, University of Cincinnati
    • Ryan Thomas Jarrett, University of Cincinnati
    • Yizhe Xu, University of Utah
    • Yu Cao, Virginia Commonwealth University
    • Xiaowu Dai, University of Wisconsin – Madison
    • Lin Dong, North Carolina State University
    • Jing Li, Indiana University
    • Brooke Ann Rabe, University of Arizona
    • Di Zhang, University of Pittsburgh
    • Heng Zhou, MD Anderson Cancer Center
    • Yanhong Zhou, MD Anderson Cancer Center

    Best Contributed Paper Award at Joint Statistical Meetings
    • First: Devan Mehrotra, Merck & Co, Survival Analysis Using a 5-STAR Approach in Randomized Clinical Trials
    • Second: Susan S. Ellenberg, University of Pennsylvania, Emerging Changes in DMC Oversight
    • Third: Wenting Cheng, Biogen, Analysis of Multiple Outcome Measures with Applications to Disability Improvement in Multiple Sclerosis
    • Honorable Mention: Paul Gallo, Novartis Pharmaceuticals, Implementing Effective DMC Decision-Making in Complex Clinical Trial Designs
    • Honorable Mention: Veronica Bunn, Takeda Pharmaceuticals, Flexible Semiparametric Bayesian Hierarchical Model for Basket Trials
    • Honorable Mention: Mary Ryan, University of California, Irvine, An Extension of Cohen’s Kappa for Clustered Data and Group Sequential Testing
    • First: James Buchanan, Covilance, LLC, Specific Safety Monitoring Tools and How This Will Benefit Drug Safety
    • Second: Barbara Hendrickson, AbbVie, Going from the Program Safety Analysis Plan to the Aggregate Safety Analysis Plan
    • Third: Lee Kennedy-Shaffer, Harvard University Department of Biostatistics, Sample Size Estimation for Stratified Cluster Randomized Trials with Binary Outcomes
    • Honorable Mention: Lothar Tremmel, CSL Behring, Quantitative Regulatory Landscape
    • Honorable Mention: Weidong Zhang, Pfizer, Leveraging Omics Biomarker in Early Clinical Trials - Concept, Utility and Impact on Decision Making
    • First: Devan Mehrotra, Qian Guan and Zifang Guo, Merck Research Laboratories, A Powerful Learn-And-Confirm Pharmacogenomics Methodology for Randomized Clinical Trials
    • Second: Alexia Lasonos, Memorial Sloan Kettering Cancer Center, Measure Differential Treatment Benefit Across Marker Specific Subgroups: The Choice of Outcome Scale
    • Third: Brian Wiens and Llya Lipkovich, Aquinox Pharmaceuticals, Inc, Implementing Multiple Imputation in Non-inferiority Clinical Trials
    • Honorable Mention: Steven A. Julious and Jo Rothwell, The University of Sheffield, A Review of the Sample Size Calculations of Randomised Controlled Trials Funded by One of the Leading Funders in the UK.
    • Honorable Mention: William R. Sones and Jonathan Cook, University of Oxford, Achieving Consensus on Guidance for Specifying the Target Difference in a RCT Sample Size Calculation – DELTA2 Project
    • First: Scott Berry, Berry Consultants, Using Little 'Go' Decisions
    • Second: Susan Urach, Medical University of Vienna, Multi-Arm Group Sequential Designs with Simultaneous Stopping Rule
    • Second: Gerald Hlavin, Medical University of Vienna, An extrapolation Framework to Specify Requirements for Drug Development in Children
    • Third: Tobias Mielke, ICON PLC, Interim Timing in Adaptive Two-Stage Dose-Finding Studies: What happens to the Expected Benefit?
    • Honorable Mention: Brian Wiens, Allergan, The Role of Multiple Imputation in Noninferiority Trials.
    • Honorable Mention: Ming Zhou, Bristol-Myers Squibb, Interim Go/No=Go Decision Making in Clinical Trials with Longitudinal Outcomes
    • First: Devan V. Mehrotra, Merck, How to Strengthen Analyses by Dropping Risky Assumptions: Three Examples
    • Second: Steven Snapinn, Amgen, Is the Median PFS Difference Meaningful for Assessing Treatment Effect?
    • Third: Kristine Broglio, Berry Consultants, A Prospective Bayesian Adaptive Trial with Hierarchical Borrowing from a Prior Single Arm Study
    • Third: Noah Simon, University of Washington Department of Biostatistics, Selection Bias in Adaptive Enrichment Designs
    • Honorable Mention: Zifang Guo, Merck, Missing Data Analysis in Crossover Studies with Baseline Measurements and Small Sample Sizes
    • Honorable Mention: Kunthel By, FDA, Ruling Out a Safety Margin
    • First: Devan V. Mehrotra, Merck & Co, More Powerful Analyzes of Crossover Trials with Baseline Measurements
    • Second: Scott R. Evans, Harvard School of Public Health, Using Endpoint Data to Analyze Patients Rather Than Patient Data to Analyze the Endpoints
    • Third: Sharon Murray, Parexel Ltd & Allison M. Florance, Novartis Oncology, Transitioning from 3+3 to N-CRM at GlaxoSmithKline
    • Honorable Mention: Richard Forshee, FDA-Center for Biologics Evaluation and Research, Communicating Benefit-Risk Analysis Results Using Graphics
    • Honorable Mention: Michael Hale, Baxalta US Inc, When is Data Transparency Useful?
    • Honorable Mention: Jesse Berlin, Johnson & Johnson, Sharing Clinical Trial Data: Recent Experience and Issues Raised
    • First: Corine Baayen, H. Lundbeck A/S & Philip Hougaard, Lundbeck, Testing Effect of a Drug Using Multiple Models for the Dose-Response
    • Second: Yonghong Gao, US Dept of Health and Human Services, Adaptive Enrichment Design in Clinical Trial
    • Third: Min Lin, Sample Size Re-Estimation in Confirmatory Studies, FDA/CBER
    • Honorable Mention: Heng Li, FDA/CDRH & Vandana Mukhi, FDA/CDRH, Design Considerations in Testing Superiority and Noninferiority Hypotheses for a Set of Secondary Endpoints
    • Honorable Mention: Nelson Lu, FDA/CDRH & Yunling Xu, FDA/CDRH, Statistical Considerations and Approaches on Using OUS Data to Support a Pre-Market Application of Medical Devices
    • First: Scott Emerson, University of Washington, Active Control Trials with Adaptive Modification of Margin to Address Nonconstancy
    • Second: Jason Connor, Berry Consultants, A Case Study of a Bayesian Adaptive Cardiology Device Trial Leading to Approval
    • Third: Steven Julious, University of Sheffield, The ABC Assumptions of Setting a Noninferiority Margin: When the Margin Assumptions Can Be Violated
    • Honorable Mention: Ilya Lipkovich, Quintiles, Strategies for Identifying Predictive Biomarkers in Clinical Trials Using Variable Importance
    • Honorable Mention: Carl Dicasoli, Vertex Pharmaceuticals, Interim Analysis of Constancy for Noninferiority Testing in Active Controlled Clinical Trials
    • First: Christopher Tong, U.S. Department of Agriculture, Concordance Correlation Coefficient Decomposed into the Product of Precision and Accuracy
    • Second: Gang Chen, Johnson & Johnson Pharmaceutical R&D, Design and Operational Issues in Clinical Trials with Adaptive Design
    • Third: Radha Railkar, Merck & Co, An Overview of Different Methods to Assess Agreement in Early Phase Clinical Trials
    • Honorable Mention: Paul Schuette, U.S. Food and Drug Administration/CDER, Confidence Intervals for Binomial Proportions with Applications to Product Safety Signaling in Drug Exposure Registries
    • First: Demidenko E
    • Second: Stroup W
    • Third: Murray SC
    • Honorable Mention: Berry D
    • Honorable Mention: Jones B
    • First: Gould A
    • Second: Chuang-Stein C
    • Third: Musser B
    • Honorable Mention: Hendrix S
    • First: Mukhi V
    • Second: Hedeker D
    • Third: Zhou Y
    • Honorable Mention: Bretz F
    • Honorable Mention: Sun X
    • First: Mehrotra D
    • Second: Hendrix S
    • Third: Mehta C
    • Honorable Mention: Greco W
    • Honorable Mention: Naftel D
    • First: Not Reported
    • Second: Nguyen H
    • Third: Remlinger K
    • First: Mehrotra D
    • Second: Dmitrienko A
    • Third: Mallinckrodt C
    • First (tied): Mehrotra D & Gennings C
    • Third: Devanarayan V
    • First: Nguyen H
    • Second: Yang P
    • Third: Baughman A
    • First: Senn S
    • Second: Mehrotra D
    • Third: Eberly L
    • First: Baggerly K
    • Second: Wiens B
    • Third: Holmgren E
    • First: Goldsmith C
    • Second: Devanarayan V
    • Third: Wiens B
    • First: Railkar R
    • Second: Bohidar N
    • Third: Helms L
    • First: Tangen C
    • Second: Mehrotra D
    • Third: Meier K

    Best Contributed Poster Award at Joint Statistical Meetings
    • First: “Impact of Direction of Treatment Effect on Composite Time-to-event Endpoint Via Win Ratio Analysis” by Ran Liao, Sujatro Chakladar, Margaret Gamalo (Eli Lilly)
    • Second: “Reginal Efficacy Evaluation in Multi-Reginal Clinical Trials Using a Discounting Factor Weighted Z Test” by XuanxuanYu, JianlingBai, Hao Yu, JingweiWu (Nanjing Medical Univ, Univ of South Carolina, Temple Univ)
    • Third: “Interim Monitoring in Sequential Multiple Assignment Randomized Trials” by Liwen Wu, Junyao Wang, and Abdus S. Wahed (Univ. of Pittsburg)
    • First: Tian Chen, Ye Feng, Shu-Pang Huang, Ming Zhou & Ramachandran Suresh, Bristol Myers-Squibb, Determination of Optimal Cut-off Points for Biomarkers in Oncology Research
    • Second: Ellen B. Gurary & Joseph Massaro, Boston University Non-Inferiority Margins in Superiority/Non-inferiority Seamless Clinical Trials
    • Third: Ronnie Wang, Daoyuan Shi, Huaming Tan, Neal Thomas, Dan Meyer, Pfizer and the University of Connecticut (Shi), Power and Type I Error for Sizing Binomial Endpoints with Unequal Randomization Ratios
    2016 2015 2014 2013
    2012 2011
    • First: Carlsson M
    • Second: Zou K
    • Third: Zhao Y
    • First: Dragomir A
    • Second: Zou K
    • Third: Gaffney M
    • First: Zou K
    • Second: Siqueira A
    • Third: Coar W

    Student Paper Award at Joint Statistical Meetings
    • First: Xinzhou Guo, University of Michigan, Inference on Selected Subgroups in Clinical Trials
    • Second: Duzhe Wang, University of Wisconsin-Madison, Boosting Algorithms for Estimating Optimal Treatment Rules
    • Third: Dana Johnson, North Carolina State University, One-Step Value Difference Test for The Existence of a Subgroup with Beneficial Treatment Effect Using Random Forests
    • Honorable Mention: Thevaa Chandereng, University of Wisconsin-Madison, Robust Blocked Response-Adaptive Randomization Designs
    • First: Ting Ye, University of Wisconsin-Madison, Validity and robustness of tests in survival analysis under covariate-adaptive randomization
    • First: Jiaying Lyu, University of Chicago, AAA: Triple-adaptive Bayesian designs for the identification of optimal dose combinations in dual-agent dose-finding trials
    • Second: David Cheng, Department of Biostatistics, Harvard University, The Statistical Performance of Matching-Adjusted Indirect Comparisons
    • Third: Arjun Sondhi, Department of Biostatistics, University of Washington, The Reduced PC-Algorithm: Improved Causal Structure Learning in Large Random Networks
    • Honorable Mention: Ting Ye, Department of Statistics, University of Wisconsin-Madison, A Robust Approach to Sample Size Calculation in Cancer Immunotherapy Trials with Delayed Treatment Effect
    • Honorable Mention: Kan Li, University of Texas Health Science Center at Houston, Bayesian Personalized Multi-Criteria Benefit-Risk Assessment of Medical Products
    • First: Nathaniel O’Connell, Medical University of South Carolina, A latent variable approach to elicit continuous toxicity scores and severity weights for multiple toxicities in dose-finding oncology trials
    • Second: Zhengling Qi, University of North Carolina at Chapel Hill, D-learning to estimate optimal individual treatment rules
    • Third: Menghan Li, Pennsylvania State University, Joint analysis of left-censored longitudinal biomarker and binary outcome via latent class modeling
    • Honorable Mention: Florica Constantine, Johns Hopkins University, A Bayesian adaptive subgroup identification enrichment design
    • Honorable Mention: Lie Li, Southern Methodist University, Meta-analysis of rare binary events in treatment groups with unequal variability
    • First: Jingxiang Chen, University of North Carolina – Chapel Hill, Estimating Individualized Treatment Rules for Ordinal Treatments
    • Second: Ailin Fan, North Carolina State University, Change-Plane Analysis for Subgroup Detection and Sample Size Calculation
    • Third: Yiyi Chu, University of Texas , Adaptive Dose Modification for Phase I Clinical Trials
    • Honorable Mention: Xin Lu, Emory University, Evaluating the Effect of Delayed PEG Insertion in Patients Diagnosed with ALS via Adaptive Treatment Length Regimens
    • Honorable Mention: Geoffrey Johnson, University of Pittsburgh, Optimizing Dynamic Treatment Regimes via Threshold Utility Analysis on Quality Adjusted Lifetime for Subgroup Analysis in Clinical Trials
    • Honorable Mention: Susanne Urach, Medical University of Vienna, Multi-arm Group Sequential Designs with Simultaneous Stopping Rule
    • Honorable Mention: Soyeon Kim, Rice University, Prediction-Oriented Marker Selection (PROMISE) with application to high-dimensional regression
    • First: Ying Liu, Columbia University, Sequential Multiple Assignment Randomization Trials
    • Second: Yebin Tao, University of Michigan, Optimal Dynamic Treatment Regimes for Treatment Initiation
    • Third: Patrick Schnell, University of Minnesota, A Bayesian Hierarchical Modeling Approach to Identifying Subgroups
    • Honorable Mention: Priyam Mitra, Rutgers University, Dose Finding Strategies In Combination Therapy
    • Honorable Mention: Lu Mao, University of North Carolina, Semiparametric Proportional Rates Regression
    • First: Yanxun Xu, University of Texas at Austin, Subgroup-Based Adaptive (SUBA) Designs for Multi-Arm Biomarker Trials
    • Second: Qing Liu, University of Pittsburgh, Landmark Proportional Subdistribution Hazards Models for Dynamic Prediction of Cumulative Incidence Probabilities
    • Third: Lee McDaniel, University of Wisconsin-Madison, Sample Size Under the Additive Hazards Model
    • Honorable Mention: Guang Yang, Rutgers University, Meta-analysis of rare events: From combining confidence intervals to combining confidence distributions
    • Honorable Mention: Pallavi S. Mishra-Kalyani, Emory University, Propensity Process for Time-varying Covariates with Application to Assessing Treatment Effect in ALS Patients
    • First: Jing Zhou, University of North Carolina, Information-Based Sample Size Re-estimation in Group Sequential Design for Longitudinal Trials
    • Second: Chen Hu, University of Michigan, A Frailty-based Progressive Multistate Model for Progression and Death in Cancer Studies
    • First: Kelley Kidwell, University of Pittsburgh, Weighted Log-rank Statistic to Compare Shared-Path Adaptive Treatment Strategies
    • Second: Jonathan Yabes, University of Pittsburgh, Semiparametric Estimation in the Proportional Subdistribution Hazards Model with Missing Cause of Failure
    • Third: Chunyan Cai, Texas MD Anderson Cancer Center, Bayesian Adaptive Phase II Screening Design for Combination Trials
    • Honorable Mention: Layla Parast, Harvard University, Landmark Estimation of Survival Incorporating Intermediate Event Information in a Randomized Clinical Trial
    • First: Vock D
    • First: Zhao S
    • Second: Cho Y
    • First: Hennessey V
    • First: Wang R
    • First: Feng W
    • First: Dai H
    • Honorable Mention: Spann M
    • Honorable Mention: Lewin D
    • First: Sun J
    • First: Chen J & McHenry M
    • Honorable Mention: Feng S
    • Honorable Mention: Wang X
    • Honorable Mention: Serban N
    • First: Wahed A, Peng X, He W, Remlinger K & Serban N
    • First: Johnson B & McNally R
    • First: Huang X, Hyslop T, Li L & Song X
    • First: Bryan J, Yu D, Somayaji V, Yu Q & Shang Z
    • First: Railkar R, Burzykowski T, Tang S & Allen A

    The "Stan Altan" Best Nonclinical Biostatistics Paper Award

    • 1st Place: Burdick, R. K., Thomas, N., & Cheng, A. (2017). Statistical considerations in demonstrating CMC analytical similarity for a biosimilar product. Statistics in Biopharmaceutical Research9(3), 249-257.
    • 2nd Place: Novick, S. J., Christian, E., Farmer, E., & Tejada, M. (2021). A Bayesian statistical approach to continuous qualification of a bioassay. PDA Journal of Pharmaceutical Science and Technology75(1), 8-23.
    • 3rd Place: Sondag, P., & Lebrun, P. (2020). Risk-based similarity testing for potency assays using MCMC simulations. Statistics in Biopharmaceutical Research, 1-10.
    • Zeng, L., Novick, S., Yu, B., and Yang, H. (2019). “General Framework for Equivalence Testing over a Range of Linear Outcomes with CMC Applications”, Statistics in Biopharmaceutical Research, 11(2), 182-190.
    • Zhang, J., Li, W., Roskos, L, and Yang H. (2017). “Immunogenicity assay cut point determination using nonparameteric tolerance limit”, Journal of Immunological Methods, 442, 29-34.
    • Novick, S., Shen, Y., Yang, H., Peterson, J., LeBlond, D., and Altan, S. (2015). “Dissolution Curve Comparisons through the F2 Parameter, a Bayesian Extension of the f2 Statistic”, Journal of Biopharmaceutical Statistics, 25(2), 351-371.Bottom of Form
    • Chen, G., Zhong, H., Belousov, A., and Devanarayan, V. (2015). “A PRIM Approach to Predictive-signature Development for Patient Stratification”, Statistics in Medicine, 34, 317–342.

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