Wei-Chen Chen E-mail: wccsnow at gmail dot com Websites: <a href="https://scholar.google.com/citations?user=vQRTsmUAAAAJ&hl=en&oi=ao" target="_blank">Google Scholar</a>, <a href="https://www.linkedin.com/in/wei-chen-chen-512b6349" target="_blank">LinkedIn</a>, and <a href="https://github.com/snoweye/" target="_blank">GitHub</a>. --- ### EXPERIENCE - Food and Drug Administration, USA. * 08/2016--present, Mathematical Statistician, Center for Devices and Radiological Health. * 08/2014--08/2016, ORISE Fellow, Center for Biologics Evaluation and Research. - Department of Ecology and Evolutionary Biology, University of Tennessee-Knoxville, USA. * 09/2013--07/2014, Postdoctoral Associate. - Computer Science and Mathematics Division, Oak Ridge National Laboratory, USA. * 08/2011--08/2013, Postdoctoral Research Associate. - Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taiwan. * 01/2001--08/2005, Research Assistant. --- ### EDUCATION - 08/2005--07/2011, Ph.D., Statistics, Iowa State University, USA. - 09/1998--06/2000, M.S., Statistics, National Central University, Taiwan. - 09/1994--06/1998, B.S., Mathematics, National Central University, Taiwan. --- ### PUBLICATIONS #### *Software* - 12 [pbdR](http://r-pbd.org/) Packages: **kazaam**, **pbdRPC**, **remoter**, **pbdZMQ**, **pbdPROF** (GSoC sponsored (2013, 2014)), **pbdDEMO**, **pbdNCDF4**, **pbdDMAT**, **pbdBASE**, **pbdSLAP**, **pbdMPI**, and **pmclust**. - 10 [R](https://r-project.org/) Packages: **psrwe**, **float**, **MixfMRI**, **getip**, **getPass**, **cubfits**, **QZ**, **EMCluster**, **phyclust**, and **MixSim**. #### *Refereed Papers* <ol id="custom" style="counter-reset: item 32"> <li id="ref"> **Chen, W.-C.**, Lu, N., Wang, C., Li, H., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q., "A propensity score-integrated approach for leveraging external data in a randomized controlled trial with time-to-event endpoints," *Pharmaceutical Statistics*, (<a href="https://doi.org/10.1002/pst.2377" target="_blank">DOI:10.1002/pst.2377</a>). </li> <li id="ref"> Li, H., **Chen, W.-C.**, Lu, N., Tang, R., and Zhao, Y. (2024), "The elusiveness of the win ratio parameter in the presence of missing data", *Therapeutic Innovation & Regulatory Science*, (<a href="https://doi.org/10.1007/s43441-024-00645-2" target="_blank">DOI:10.1007/s43441-024-00645-2</a>). </li> <li id="ref"> Lu, N., **Chen, W.-C.**, Li, H., Song, C., Tiwari, R., Wang, C., Xu, Y., and Yue, L.Q. (2024), "Propensity score-incorporated adaptive design approaches when incorporating real-world data," *Pharmaceutical Statistics*, **32**(2), 204--218. </li> <li id="ref"> Tang, R., **Chen, W.-C.**, Li, H., Lu, N., and Zhao, Y. (2024), "The Finkelstein-Schoenfeld test: A note on some overlooked issues concerning power," *Therapeutic Innovation & Regulatory Science*, (<a href="https://doi.org/10.1007/s43441-023-00608-z" target="_blank">DOI:10.1007/s43441-023-00608-z</a>). </li> <li id="ref"> **Chen, W.-C.** and Maitra, R. (2023), "A practical model-based segmentation approach for improved activation detection in single-subject functional magnetic resonance imaging studies," *Human Brain Mapping*, **44**(16), 5309--5335. </li> <li id="ref"> Song, C., Li, H., **Chen, W.-C.**, Lu, N., Tiwari, R., Wang, C., Xu, Y., and Yue, L.Q. (2023), "Principled leveraging of external data in the evaluation of diagnostic devices via the propensity score-integrated composite likelihood approach," *Pharmaceutical Statistics*, **22**(3), 547--569. </li> <li id="ref"> Li, H., Wang, C., **Chen, W.-C.**, Lu, N., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Estimands in observational studies: Some considerations beyond ICH E9 (R1)," *Pharmaceutical Statistics*, **21**(5), 835--844. </li> <li id="ref"> **Chen, W.-C.**, Lu, N., Wang, C., Li, H., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Propensity Score-Integrated Approach to Survival Analysis: Leveraging External Evidence in Single-Arm Studies," *Journal of Biopharmaceutical Statistics*, **32**(3), 400--413. </li> <li id="ref"> Lu, N., Wang, C., **Chen, W.-C.**, Li, H., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Propensity score-integrated power prior approach for augmenting the control arm of a randomized controlled trial by incorporating multiple external data sources," *Journal of Biopharmaceutical Statistics*, **32**(1), 158--169. </li> <li id="ref"> Lu, N., Wang, C., **Chen, W.-C.**, Li, H., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Leverage multiple real-world data sources in single-arm medical device clinical studies," *Journal of Biopharmaceutical Statistics*, **32**(1), 107--123. </li> <li id="ref"> Li, H., **Chen, W.-C.**, Wang, C., Lu, N., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Augmenting both arms of a randomized controlled trial using external data: An application of the propensity score-integrated approaches," *Statistics in Biosciences*, **14**, 79--89. </li> <li id="ref"> Li, H., **Chen, W.-C.**, Lu, N., Song, C., Wang, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2022), "Mitigating Study Power Loss Caused by Clinical Trial Disruptions Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches," *Statistics in Biopharmaceutical Research*, **14**(1), 87--91. </li> <li id="ref"> Wang, C., Rosner, G.L., Bao, T., Lu, N., **Chen, W.-C.**, Li, H., Tiwari, R., Xu, Y., and Yue, L.Q. (2021), "Leveraging real-world evidence for determining performance goals for medical device studies," *Statistics in Medicine*, **40**(29), 6577--6589. </li> <li id="ref"> **Chen, W.-C.**, Li, H., Wang, C., Lu, N., Song, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2021), "Evaluation of Diagnostic Tests for Low Prevalence Diseases: A Statistical Approach for Leveraging Real-World Data to Accelerate the Study," *Journal of Biopharmaceutical Statistics*, **31**(3), 375--390. </li> <li id="ref"> Li, H., **Chen, W.-C.**, Lu, N., Wang, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2020), "Novel Statistical Approaches and Applications in Leveraging Real-World Data in Regulatory Clinical Studies," *Health Services and Outcomes Research Methodology*, **20**, 237--246. </li> <li id="ref"> **Chen, W.-C.**, Wang, C., Li, H., Lu, N., Tiwari, R., Xu, Y., and Yue, L.Q. (2020), "Propensity Score-Integrated Composite Likelihood Approach for Augmenting the Control Arm of a Randomized Controlled Trial by Incorporating Real-World Data," *Journal of Biopharmaceutical Statistics*, **30**(3), 508--520. </li> <li id="ref"> Wang, C., Lu, N., **Chen, W.-C.**, Li, H., Tiwari, R., Xu, Y., and Yue, L.Q. (2020), "Propensity Score-Integrated Composite Likelihood Approach for Incorporating Real-World Evidence in Single-Arm Clinical Studies," *Journal of Biopharmaceutical Statistics*, **30**(3), 495--507. </li> <li id="ref"> Wang, C., Li, H., **Chen, W.-C.**, Lu, N., Tiwari, R., Xu, Y., and Yue, L.Q. (2019), "Propensity Score-Integrated Power Prior Approach for Incorporating Real-World Evidence in Single-Arm Clinical Studies," *Journal of Biopharmaceutical Statistics*, **29**(5), 731--748. </li> <li id="ref"> Schmidt, D., **Chen, W.-C.**, Matheson, M., and Ostrouchov, G. (2017), "Programming with BIG Data in R: Scaling Analytics from One to Thousands of Nodes," *Big Data Research*, **8**, 1--11. </li> <li id="ref"> Li, J.X., **Chen, W.-C.** and Scott, J.A. (2016), "Addressing Prior-data Conflict with Empirical Meta-Analytic-Predictive Priors in Clinical Studies with Historical Information," *Journal of Biopharmaceutical Statistics*, **16**(6), 1056--1066. </li> <li id="ref"> Schmidt, D., **Chen, W.-C.**, and Ostrouchov, G. (2016), "Introducing a New Client/Server Framework for Big Data Analytics with the R Language," *Proceedings of the XSEDE16 Conference on Diversity, Big Data, and Science at Scale*, **38**, 1--9. </li> <li id="ref"> Gilchrist, M.A., **Chen, W.-C.**, Shah, P., Landerer, C.L., and Zaretzki, R. (2015), "Estimating Gene Expression and Codon-Specific Translational Efficiencies, Mutation Biases, and Selection Coefficients from Genomic Data Alone," *Genome Biology and Evolution*, **7**(6), 1559--1579. </li> <li id="ref"> **Chen, W.-C.**, Ostrouchov, G., Pugmire, D., Prabhat, and Wehner, M. (2013), "A Parallel EM Algorithm for Model-Based Clustering Applied to the Exploration of Large Spatio-Temporal Data," *Technometrics*, **55**(4), 513--523. </li> <li id="ref"> Melnykov, V., **Chen, W.-C.**, and Maitra, R. (2012), "MixSim: An R Package for Simulating Data to Study Performance of Finite Mixture Modeling and Clustering Algorithms," *Journal of Statistical Software*, **51**(12), 1--25. </li> <li id="ref"> Schmidt, D., Ostrouchov, G., **Chen, W.-C.**, and Patel, P. (2012), "Tight Coupling of R and Distributed Linear Algebra for High-Level Programming with Big Data," *High Performance Computing, Networking, Storage and Analysis (SCC), 2012 SC Companion:*, 811--815. </li> <li id="ref"> **Chen, W.-C.** and Maitra, R. (2011), "Model-Based Clustering of Regression Time Series Data via APECM -- An AECM Algorithm Sung to an Even Faster Beat," *Statistical Analysis and Data Mining*, **4**(6), 567--578. (Student Paper Competition Winner). </li> <li id="ref"> Carpenter, S., **Chen, W.-C.**, and Dorman, K.S. (2011), "Rev Variation during Persistent Lentivirus Infection," *Viruses*, **3**, 1--12. </li> <li id="ref"> **Chen, W.-C.** and Maiti, T. (2007), "Analysis of cDNA Microarray Experiment with External Controls: A Mixed Model Approach," *Calcutta Statistical Association Bulletin*, **59**, 117--135 (by invitation). </li> <li id="ref"> Wen, C.-C., Wu, Y.-J., Huang, Y.-H., **Chen, W.-C.**, Liu, S.-C., Jiang, S.-S., Juang, J.-L., Lin, C.-Y., Fang, W.-T., Hsiung, C.A., and Chang, I.-S. (2006), "A Bayes Regression Approach to Array-CGH Data," *Statistical Applications in Genetics and Molecular Biology*, **5**(1), Article 3. </li> <li id="ref"> Fan, T.-H. and **Chen, W.-C.** (2005), "A Bayesian Change Points Analysis of the Seismic Activity in Northeastern Taiwan," *Journal of Statistical Computation and Simulation*, **75**(11), 857--868. </li> <li id="ref"> Juang, J.-L., Chen, T.-C., Jiang, S.-S., Hsiung, C.A., **Chen, W.-C.**, Chen, G.-W., Lin, S.-M., Lin, J.-H., Chiu, S.-C., and Lai, Y.-K. (2004), "Coupling Multiplex RT-PCR to a Gene Chip Assay for Sensitive and Semiquantitative Detection of Severe Acute Respiratory Syndrome-Coronavirus," *Laboratory Investigation*, **84**(9), 1085--1091. </li> </ol> #### *Paper Relesed on [arXiv.org](https://arxiv.org/)* <ol id="custom" style="counter-reset: item 3"> <li id="ref"> **Chen, W.-C.**, and Maitra, R. (2021), "A Practical Model-based Segmentation Approach for Accurate Activation Detection in Single-Subject functional Magnetic Resonance Imaging Studies." (<a href="https://arxiv.org/abs/2102.03639" target="_blank">arXiv:2102.03639</a>). </li> <li id="ref"> Ostrouchov, G., **Chen, W.-C.**, and Schmidt, D. (2017), "Parallel Statistical Computing with R: An Illustration on Two Architectures." (<a href="https://arxiv.org/abs/1709.01195" target="_blank">arXiv:1709.01195</a>). </li> </ol> #### *Conference Presentations* <ol id="custom" style="counter-reset: item 16"> <li id="ref"> **Chen, W.-C.**, Li, H., and Yue, L.Q. (2024), "Leveraging Real-World Evidence via a Hybrid Study Design with a Time-to-Event Endpoint," FDA/AdvaMed Medical Device Statistical Issues (MDSI) Conference, Washington, DC, USA. (Joint work with Nelson Lu, Changhong Song, Ram Tiwari, Chenguang Wang, and Yun-Ling Xu). </li> <li id="ref"> **Chen, W.-C.**, Li, H., and Yue, L.Q. (2023), "Leveraging Real-World Evidence via a Hybrid Study Design with a Time-to-Event Endpoint," 2023 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Rockville, MD, USA. (Joint work with Nelson Lu, Changhong Song, Ram Tiwari, Chenguang Wang, and Yun-Ling Xu). </li> <li id="ref"> **Chen, W.-C.** (2022), "On the Usage of Propensity Score-Integrated Approach," 14th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference, Virtual Conference. (Joint work with Heng Li, Nelson Lu, Changhong Song, Ram Tiwari, Chenguang Wang, Yun-Ling Xu, and Lilly Q. Yue). </li> <li id="ref"> **Chen, W.-C.**, Li, H., Lu, N., Song, C., Tiwari, R., Wang, C., Xu, Y., and Yue, L.Q. (2021), "Evaluation of Diagnostic Tests for Low Prevalence Diseases with Leveraging Real-World Data," 2021 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Virtual Workshop. </li> <li id="ref"> **Chen, W.-C.**, Li, H., Lu, N., Song, C., Wang, C., Tiwari, R., Xu, Y., and Yue, L.Q. (2021), "Evaluation of Diagnostic Tests for Low Prevalence Diseases with Leveraging Real-World Data," Biometrics Section, JSM2021, Virtual Conference. </li> <li id="ref"> **Chen, W.-C.** (2019), "A Case Study of Analyzing Recurrent and Terminal Events Using Joint Frailty Model," 12th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference, Washington, DC, USA. (Joint work with Vandana Mukhi, Heng Li, and Yun-Ling Xu). </li> <li id="ref"> **Chen, W.-C.**, Schmidt, D., and Ostrouchov, G. (2018), "The pbdR Project: Distributed Computing with R," Section on Statistical Computing, JSM2018, Vancouver, BC, Canada. (Invited). <a href="https://github.com/RBigData/R_JSM2018/blob/master/presentation/main.pdf" target="_blank">pdf</a> </li> <li id="ref"> **Chen, W.-C.** (2018), "Phyloclustering: A Model-Based Approach for Identifying Microbial Populations," Symposium on Data Science and Statistics, Reston, VA, USA. (Invited). <a href="https://github.com/snoweye/SDSS2018/blob/master/main.pdf" target="_blank">pdf</a> </li> <li id="ref"> **Chen, W.-C.** and Lu, N. (2017), "A Bayesian Approach Developed for Single Arm Studies using Performance Goals with Subgroups," Section on Medical Devices and Diagnostics, JSM2017, Baltimore, MD, USA. </li> <li id="ref"> **Chen, W.-C.**, Schmidt, D., and Ostrouchov, G. (2016), "Interactive Terabytes with pbdR," UseR! 2016, Stanford, CA, USA. <a href="https://github.com/snoweye/user2016.demo" target="_blank">Demo</a> </li> <li id="ref"> **Chen, W.-C.**, Ostrouchov, G., Pugmire, D., Prabhat, and Wehner, M. (2012), "Model-Based Clustering Analysis of Large Climate Simulation Datasets," Section on Statistical Computing, JSM2012, San Diego, CA, USA. </li> <li id="ref"> **Chen, W.-C.** and Maitra, R. (2011), "A New AECM Algorithm Tuned to A Faster Beat for Model-Based Clustering of Regression Time Series Data," Section on Statistical Learning and Data Mining, JSM2011, Miami, FL, USA. (Student Paper Competition Winner). </li> <li id="ref"> **Chen, W.-C.**, Dorman, K.S., Lunney, J.K., and Rowland, R.R.R. (2011), "Model-Based Functional Clustering for Porcine Reproductive and Respiratory Syndrome Virus Data," SCVMMI, Clarke University, Dubuque, IA, USA. </li> <li id="ref"> Melnykov, V., **Chen, W.-C.**, and Maitra, R. (2010), "Model-Based Semisupervised Clustering," Biometrics Section, JSM2010, Vancouver, BC, Canada. </li> <li id="ref"> **Chen, W.-C.** and Dorman, K.S. (2009), "Twisted Sisters: Disentangling Selection in Overlapping Reading Frames," Section on Statistical Computing, JSM2009, Washington, DC, USA. (Student Paper Competition Winner). </li> </ol> #### *Posters* <ol id="custom" style="counter-reset: item 15"> <li id="ref"> Song, C., Li, H., **Chen, W.-C.**, Lu, N., Tiwari, R., Wang, C., Xu, Y., and Yue, L. (2023), "Principled leveraging of real-world evidence in the evaluation of diagnostic devices via the propensity score-integrated composite likelihood approach," 2023 FDA Science Forum, Silver Spring, MD, USA. </li> <li id="ref"> Song, C., **Chen, W.-C.**, Li, H., Lu, N., Tiwari, R., Wang, C., Xu, Y., and Yue, L. (2023), "Leveraging Real World Data in the Evaluation of Diagnostic Devices via the Propensity Score-Integrated Composite Likelihood Approach," 15th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference, Washington, DC, USA. </li> <li id="ref"> Yue, L., **Chen, W.-C.**, Li, H., Lu, N., Song, C., Wang, C., Tiwari, R., and Xu, Y. (2021), "Mitigating Study Power Loss in Clinical Studies Disrupted Due to the COVID-19 Pandemic: Leveraging External Data via Propensity Score-Integrated Approaches", 2021 FDA Science Forum, Silver Spring, MD, USA. </li> <li id="ref"> **Chen, W.-C.**, Li, H., Lu, N., Song, C., Tiwari, R., Wang, C., Xu, Y. (2020), and Yue, L., "Novel Statistical Approaches for Leveraging Real-World Data to Support Regulatory Decisions," 2020 FDA Scientific Computing Days, Silver Spring, MD, USA. </li> <li id="ref"> Yue, L., **Chen, W.-C.**, Li, H., Lu, N., Tiwari, R., Wang, C., and Xu, Y. (2019), "Leveraging Real-World Data for Regulatory Decision-Making: A Novel Statistical Approach for Augmenting Patient Cohort in the Investigational Clinical Studies," 2019 FDA Science Forum, Silver Spring, MD, USA. </li> <li id="ref"> **Chen, W.-C.**, Li, H., Lu, N., Tiwari, R., Wang, C., Xu, Y., and Yue, L. (2019), "Leveraging Real-World Data and Incorporating Real-World Evidence: Harnessing Real-World Factors," 12th Annual FDA/AdvaMed Medical Devices and Diagnostics Statistical Issues Conference, Washington, DC, USA. </li> <li id="ref"> **Chen, W.-C.**, Li, J., and Scott, J. (2016), "Subgroup Analyses for Count Data using Bayesian Empirical Meta-Analytical Predictive Priors," 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Washington, DC, USA. </li> <li id="ref"> **Chen, W.-C.**, Li, J., and Scott, J. (2016), "Subgroup Analyses for Count Data using Bayesian Empirical Meta-Analytical Predictive Priors," Biopharmaceutical Section, JSM2016, Chicago, IL, USA. </li> <li id="ref"> **Chen, W.-C.** and Maitra, R. (2016), "A Novel Model-based Segmentation Approach for Improved Activation Detection in fMRI Studies," ISMRM 24th Annual Meeting, Singapore. </li> <li id="ref"> **Chen, W.-C.**, Li, J., Scott, J., and Mintz, P. (2015), "Bayesian-Commensurate Approach for Safety Assessment in Clinical Studies with Count Outcomes," Biopharmaceutical Section, JSM2015, Seattle, WA, USA. </li> <li id="ref"> **Chen, W.-C.**, Zaretzki, R., and Gilchrist, M. (2014), "cubfits: an R package for codon usage bias fits," Society for Molecular Biology and Evolution, SMBE2014, San Juan, Puerto Rico </li> <li id="ref"> **Chen, W.-C.**, Ostrouchov, G., Pugmire, D., Prabhat, and Wehner, M. (2012), "Applying model-based clustering for analysis of Community Atmospheric Model output," Conference on Data Analysis (CoDA), Statistical Sciences Group, Los Alamos National Laboratory, Santa Fe, NM, USA. </li> <li id="ref"> Dorman, K.S. and **Chen, W.-C.** (2008), "Overlapping Codon Model for Detecting Selection Effects in Overlapping Reading Frames," Fall Conference on Statistics in Biology 2008, Iowa State University, Ames, Iowa, USA. </li> <li id="ref"> **Chen, W.-C.**, Lin, C.-Y., Huang, Y.-S., Chang, I.-S., and, Hsiung, C.A. (2004), "Microarray On Line Analysis System (MOLAS): A web platform for array data management and analysis," Intelligent Systems for Molecular Biology, ISMB2004, Glasgow, Scotland, UK. </li> </ol> --- ### SERVICES #### *FDA Advisory Committees* - Member of Review Team for Hypertension Renal Denervation Panel: Discuss, make recommendations, and vote on information regarding the premarket approval application (PMA) for the "ReCor Paradise Ultrasound Renal Denervation System" and the "Medtronic Inc. Symplicity Spyral Renal Denervation System," Circulatory System Devices Panel Meeting, Aug. 22-23, 2023. (Executive Summary: <a href="https://www.fda.gov/media/171388/download" target="_blank">Aug. 22</a> and <a href="https://www.fda.gov/media/171411/download" target="_blank">Aug. 23</a>; Presentation: <a href="https://youtu.be/Guz-BWP6cQc" target="_blank">Aug. 22</a> and <a href="https://youtu.be/Gb2UZPVCgms" target="_blank">Aug. 23</a>) (Public Media: <a href="https://www.tctmd.com/news/recors-renal-denervation-system-gets-thumbs-fda-advisory-panel" target="_blank">Aug. 22</a> and <a href="https://www.tctmd.com/news/medtronics-renal-denervation-system-fails-sway-fda-advisory-panel" target="_blank">Aug. 23</a>) - Member of Review Team for General Issues Panel: "Clinical Evaluation of Anti-Hypertensive Devices," Circulatory System Devices Panel Meeting, Dec. 5, 2018. (<a href="https://www.fda.gov/media/123038/download" target="_blank">Executive Summary</a>, <a href="https://www.fda.gov/media/123040/download" target="_blank">Presentation</a>, <a href="https://www.fda.gov/media/123044/download" target="_blank">Panel Questions</a>, and <a href="https://www.fda.gov/media/123039/download" target="_blank">24 Hour Summary</a>) <a href="https://www.tctmd.com/news/fda-charts-path-resurrection-device-based-antihypertensive-therapies?utm_source=TCTMD&utm_medium=email&utm_campaign=Newsletter120618" target="_blank">Public Media</a> #### *FDA Office of the Chief Scientist (OCS) Intramural Grant Proposal Review* - *Office of Women's Health (OWH) Intramural Scientific Research Funding Proposal* (FY2020). #### *NESTcc Research Methods and Data Quality Subcommittees* - Member of Research Methods Subcommittee: "Support NESTcc's efforts to conduct efficient, timely, and high-quality real-world evidence (RWE) studies for medical devices,'' (2021--present). #### *Journal Editorship* - 11/2021--present, Associate Editor, *Pharmaceutical Statistics*. - 07/2018--present, Associate Editor, *Statistical Analysis and Data Mining: The ASA Data Science Journal*. #### *Journal Manuscript Reviews* - *Statistical Analysis and Data Mining: The ASA Data Science Journal* (2024(×2), 2021(×2), 2020(×2), 2019(×3), 2018). - *Pharmaceutical Statistics* (2024(×15), 2023(×13), 2022(×9), 2021(×2), 2017, 2016(×2), 2015). - *The New England Journal of Statistics in Data Science* (2024). - *Statistics in Biosciences* (2024(×2)). - *Communications in Statistics - Case Studies and Data Analysis* (2024(×2)). - *Journal of Biopharmaceutical Statistics* (2023(×2), 2022(×2), 2021(×4), 2020(×3), 2019). - *The R Journal* (2022, 2021, 2019(×2), 2018). - *Statistics in Biopharmaceutical Research* (2022, 2021(×2), 2015). - *Statistics in Medicine* (2019, 2018). - *Psychological Methods* (2018(×2)). - *Journal of Computational and Graphical Statistics* (2018). - *Methods in Ecology and Evolution* (2015(×2), 2011). - *Journal of Statistical Software* (2015, 2012). - *Technometrics* (2013). #### *Conference Manuscript and Poster Reviews* - *Biopharmaceutical Section Joint Statistical Meeting Poster Competition* (2016(×2), 2015(×4)). - *IEEE International Conference on Networking, Architecture, and Storage* (2012). #### *Conference Organizing Activity* - Session Organizer: "From Bayesian Statistics to Machine Learning and Artificial Intelligence: Innovation and Adaptation of Safety Assessment," 2018 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Washington, DC, USA. - Session Chair: "Clustering Methods for Big Data Problems," Section on Statistical Learning and Data Science, JSM2017, Baltimore, MD, USA. - Session Organizer: "Personalized Medicine: How Bayesian Subgroup Analysis Plays Its Role," 2016 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Washington, DC, USA. - Session Chair: "Dimension Reduction and Semiparametric Modeling," IMS, JSM2011, Miami Beach, FL, USA. --- ### TEACHING & MENTORING EXPERIENCE #### *Tutorial and Short Courses* <ol id="custom" style="counter-reset: item 8"> <li id="rev"> Chenguang Wang, Nelson Lu, and **Chen, W.-C.** (2022), "Leveraging Real-World Data in Medical Product Clinical Trials Design and Analysis," 2022 ASA Biopharmaceutical Section Regulatory-Industry Statistics Workshop, Washington, DC, USA. </li> <li id="rev"> **Chen, W.-C.** (2022), "Borrow External Data II: Frequentist Approach," Statistics for Clinical Trials with Application to Medical Device Studies, Lecture 11, FDA/CDRH, Virtual. </li> <li id="rev"> **Chen, W.-C.** (2020), "General Statistical Issues in Designing Superiority and Non-inferiority Randomized Controlled Trial," Introductory Statistics Short Course for OHT2 (Office of Cardiovascular Devices), Lecture 3, FDA/CDRH, Silver Spring, MD, USA. </li> <li id="rev"> **Chen, W.-C.** (2019), "Pooling Data and Meta-analysis," Statistics for Clinical Trials with Application to Medical Devices, Session 5 Lecture 9, FDA/CDRH, Silver Spring, MD, USA. </li> <li id="rev"> **Chen, W.-C.** (2017), "Pooling Data and Meta-analysis," Statistics for Clinical Trials with Application to Medical Devices, Session 5 Lecture 8, FDA/CDRH, Silver Spring, MD, USA. </li> <li id="rev"> Ostrouchov, G. and **Chen, W.-C.** (2017), "Essentials of High Performance and Parallel Statistical Computing with R," Continuing Education Course, JSM2017, Baltimore, MD, USA. <a href="http://pbdr.org/tutorials/jsm2017/" target="_blank">Material</a> </li> <li id="rev"> **Chen, W.-C.**, Zaretzki, R., and Gilchrist, M. (2014), "Fitting Complex Mixed Models using HPC," NIMBioS Tutorial (Computing in the Cloud: What Every Computational Life Scientist Should Know), University of Tennessee, Knoxville, TN, USA. <a href="https://snoweye.github.io/pbdr/tutorial3.html" target="_blank">Material</a> </li> </ol> #### *Mentorship and Student Supervision* <ol id="custom" style="counter-reset: item 9"> <li id="rev"> Chunxiao Wang, Stat PhD, Oregon State University. 2017 Summer at FDA/CDRH/OSB/DBS. </li> <li id="rev"> Baosheng He, Industrial Engineering PhD, University of Iowa. 2016 Summer at ORNL/JICS. </li> <li id="rev"> Yuping Lu, EE&CS PhD, University of Tennessee, Knoxville. 2016 Summer at ORNL. </li> <li id="rev"> Christian Heckendorf, CS MS, Boston University. 2014 Summer at Google Summer of Code. </li> <li id="rev"> Gaurav Sehrawat, BS, Jaypee Institute of Information Technology, India. 2013 Summer at Google Summer of Code. </li> <li id="rev"> Cristian Capdevila, CS BS, University of Tennessee, Knoxville. 2012 Summer at ORNL. </li> <li id="rev"> John Aidoo, Applied Stat MS, Wright State University. 2010 Summer at Iowa State University. </li> <li id="rev"> Benjamin Deonovic, BCB&Math BS, Iowa State University. 2010 Summer at Iowa State University. </li> </ol> --- ### HONORS & AWARDS <ol id="custom" style="counter-reset: item 10"> <li id="rev"> 2024 The 64th Annual FDA Honor Awards: Commissioner's Special Citation (Renal Denervation to Treat Hypertension Premarket Review Team) -- "For exhaustive efforts over the past decade to support evaluation of breakthrough device therapies to treat hypertension." With several FDA colleagues. </li> <li id="rev"> 2022 CDRH/FDA Honor Awards: The CDRH Excellence in Communications and Education Award (Breast Implant and Acellular Dermal Matrix Communication Team) -- "For outstanding contributions in warning the public about complications from Acellular Dermal Matrixes for breast reconstruction and breast implant risks." With several FDA colleagues. </li> <li id="rev"> 2020 CDRH/FDA Honor Awards: The CDRH Excellence in Scientific Research Award (External Evidence Methods Research Team) -- "For the timely development of statistical methods for the transformation of real-world data into real-world evidence that can support regulatory decision-making." With Heng Li, Nelson Lu, Ram Tiwari, Yunling Xu, Lilly Q. Yue, and Chenguang Wang. </li> <li id="rev"> 2020 FDA Scientific Achievement Award: Excellence in Analytical Science (RWE Methods Group) -- "For extraordinary achievements in the timely development and active promotion of novel statistical methods for leveraging real-world evidence to support regulatory decision-making." With Heng Li, Nelson Lu, Ram Tiwari, Chenguang Wang, Yunling Xu, and Lilly Q. Yue. <a href="https://www.fda.gov/science-research/about-science-research-fda/excellence-analytical-science-group-award-2009-present" target="_blank">Public Media</a> </li> <li id="rev"> 2016 Significant Event Award (SEA) at the Oak Ridge National Laboratory for "Harnessing HPC Capability at OLCF with the R Language for Deep Data Science" on HPCwire. <a href="https://www.hpcwire.com/2016/07/06/olcf-researchers-scale-r-tackle-big-science-data-sets/" target="_blank">Public Media</a> </li> <li id="rev"> 2011 Vince Sposito Award for Excellence in Statistical Computing, Department of Statistics, Iowa State University. </li> <li id="rev"> 2011 ASA Statistical Learning and Data Mining Student Paper Competition Award. </li> <li id="rev"> 2010 Preparing Future Faculty, Iowa State University. </li> <li id="rev"> 2009 ASA Statistical Computing/Statistical Graphics Student Paper Competition Award. </li> </ol> --- ### COMPUTER SKILLS - **Statistical Software**: R, JAGS, WinBUGS/OpenBUGS. - **Programming Languages**: C, Fortran, Perl. - **Web Development Tools**: PHP, Html, CGI. - **Database**: MySQL. - **Operating Systems**: Linux/Unix, Solaris, MS-Windows. - **Parallel Computing Libraries**: OpenMPI, MPICH, MS-MPI. - **Network Related**: Apache, SSL, Samba, NFS, NIS, SSH, ZeroMQ. - **Others**: TeX/LaTeX, Shell Script, vi, Word, Excel, PowerPoint. --- Maintained: Wei-Chen Chen E-Mail: wccsnow at gmail dot com Last Updated: October 14, 2024 Created: July 25, 2016