D. Personnel

Faculty and staff biostatistics in the Design, Biostatistics, and Clinical Research Ethics Program who will be devoted to VICTR represent a broad spectrum of expertise in virtually every area of biostatistics (including survival analysis, longitudinal data analysis, predictive modeling, clinical trials methodology, Bayesian modeling, robust estimation, nonparametric statistics, missing data, observational data analysis, exploratory data analysis, the bootstrap, model validation, and analysis of high density data), experimental design, and statistical computing. The biostatisticians listed below also have extensive experience in most biomedical research areas; several have significant experience with FDA and drug development. The group is well positioned to catalyze translational and clinical research in many ways. To further support VICTR, the department plans to continue to recruit biostatisticians with proven collaboration skills who will be resources in many methodologic areas. Personnel also includes nationally known experts in clinical research ethics.

Frank E. Harrell Jr., Ph.D., Professor of Biostatistics and Chair, Department of Biostatistics (25% effort with salary), has experience in clinical trials, development of accurate prognostic and diagnostic models, health services and outcomes research, technology evaluation, observational databases, statistical modeling strategies, model validation, analysis of incomplete data, statistical computing, reproducible analysis and research, Bayesian analysis, and teaching quantitative and graphical methods to biomedical researchers. His major current interest is pharmaceutical safety, related to developing better ways to present safety information to data monitoring committees and developing new methods for pharmaceutical researchers to explore clinical chemistry, hematology, adverse events, and ECG data in Phase II and III randomized clinical trials. He is an Associate Editor of Statistics in Medicine and a Fellow of the American Statistical Association. He is author of the text Regression Modeling Strategies, has more than 170 peer-reviewed publications, and has been an expert consultant to FDA since 1987. He currently directs the Department of Biostatistics' Statistical Analysis Center for three pharmaceutical industry-sponsored Data Monitoring Committees for multi-center clinical trials. He will direct and be responsible for all aspects of the Design, Biostatistics, and Clinical Research Ethics Program and its interactions with VICTR as a whole. He will also be responsible for the integration of the clinical research ethicists (Drs. Clayton, Churchill, and Heitman) into the VICTR study design review process. He will continue to develop model validation procedures that will be applied to high-dimensional data analysis projects in CTSA, to guard against overstating effects of diagnostic and prognostic markers. He will also apply modern biostatistical methods to the analysis of drug safety data for detection of early safety signals.

Daniel W. Byrne, M.S., Senior Associate in Biostatistics, Department of Biostatistics (55% effort with salary) has 23 years of experience in clinical research and biostatistical consulting. His areas of expertise are statistical analysis of clinical research data, efficiency in biostatistics and publishing medical research, and effectiveness of biostatistical teaching. For the past 6 years he has held the position of Director of Biostatistics and Study Design, for the General Clinical Research Center. In this role, he has been intimately involved with study design and statistical analysis for a wide variety of clinical research projects. He has also played a major role in researching the research process for example by studying factors associated with time to publication of GCRC projects. This work is a continuation of the research from his first book Publishing Your Medical Research Paper, which describes the reasons medical manuscripts are accepted or rejected for publication. He is also an award-winning teacher in the field of biostatistics and is working on a second book, which will be an introductory biostatistics textbook. In his work at Vanderbilt, he has introduced several innovative methods, including an evidence-based method of teaching biostatistics, GCRC Biostatistics Clinic, and extreme consulting. During his 6 year at Vanderbilt's GCRC the number of GCRC publications has doubled. He will assist Dr. Harrell in the functioning of the Design, Biostatistics, and Clinical Research Ethics Program and the analysis of metrics to assess the efficiency of the research process.

Chang Yu, Ph.D., Assistant Professor of Biostatistics, Department of Biostatistics (50% effort with salary), has experience in developing new statistical methods in the areas of distributions and analysis methods for correlated binary data, permutation tests for small sample problems, measurement error models, and time series data. He has collaborative research experience in the settings of biostatistics and data coordinating center, Phases I, II, III, and IV clinical trials in the pharmaceutical industry, and academic medical centers. Dr. Yu's responsibilities will include design, review, and analysis of studies with focus on clinical trials, drug efficacy and safety evaluations, and studies with non-traditional design or novel sampling plans. Dr. Yu currently serves as the Director of Biostatistical Research for the GCRC at Vanderbilt at 50% effort. Together with Mr. Byrne, Dr. Yu will be in charge of all design and review operations of the DBCRE Program, including assigning other DBCRE personnel to reviews and design requests.

William D. Dupont, Ph.D., Professor of Biostatistics and Preventive Medicine, (10% effort with salary) has experience in chronic disease epidemiology, clinical trials, survival analysis, generalized linear models, repeated-measures analysis of variance, time series analysis, statistical graphics, data management and quality assurance, and techniques for model fitting and residual analysis. His major current interest is the study of the molecular epidemiology of breast cancer and he has been the Principal Investigator on a series of NIH R01 grants on this topic. He has eight years of experience teaching intermediate level biostatistics to clinical fellows in Vanderbiltís MPH program and has written a biostatistics text aimed at this audience. He has served as a member of numerous NIH review committees. He is an Associate Editor of The Stata Journal and has served on the editorial advisory boards of Cancer and The Breast. His methods research has included techniques for sample size estimation and power calculations, statistical graphics, the estimation of animal abundance, and the philosophical foundations of statistical inference. He will be primarily responsible for the design, review and analysis of studies involving chronic disease.

Yu Shyr, Ph.D. (10% effort with salary), Ingram Professor of Cancer Research, Professor of Biostatistics, and Director of Biostatistics Shared Resource at Vanderbilt-Ingram Cancer Center. Dr. Shyr has been with the Vanderbilt-Ingram Cancer Center for more than eleven years, specializing in the statistical analysis of cancer studies. He has served on a number of NIH/NCI SPORE review and PO1 review committees. Dr. Shyr currently serves as the member of the NCI Developmental Therapeutic Study Section. His methodological contributions to statistics encompass techniques of multivariate data analysis, statistical methods in estimation of relative potency in a parallel line bioassay, and modeling the quasi-sinusoidality of time-oriented data. His current research interests focus on the analyses of gene expression array and protein expression profile data to identify the molecular "fingerprint" of human cancers. Dr. Shyr has delivered more than 130 abstracts to professional meetings and has published more than 160 peer-reviewed papers in a variety of journals. He will be responsible for for teaching clinical trials methodology to VICTR investigators and for developing rigorously scientific designs for new CTSA studies.

Dean Billheimer, Ph.D. (10% effort, with salary) Assistant Professor of Biostatistics, has extensive experience in the development and application of novel analysis methods to high-dimensional parameter problems, especially in proteomics (e.g., matrix assisted laser desorption/ionization time-of-flight mass spectrometry, MALDI-TOF MS), and spatial statistics. Technically, this research involves nonparametric regression, statistical computing, Bayesian inference, and the theory of normalization. Dr. Billheimer also has wide-ranging collaborative experience in environmental science, the aerospace industry, and biomedicine. These collaborations involve statistical design of clinical trials and controlled experiments, analysis of complex data sets, and biomarker discovery and development. Further, he has a 'recreational' interest in the philosophy of scientific inference and its relation to statistical inference. He has been at Vanderbilt since 2001, and is a member of the Vanderbilt-Ingram Cancer Center. He will be responsible for development of novel biomarker discovery, analysis, and validation procedures and for analysis of proteomic data.

Qingxia Chen, Ph.D., Assistant Professor of Biostatistics, Department of Biostatistics (40% effort with salary), has experience in the analysis of incomplete data, Bayesian analysis, clinical trials, health service research, longitudinal and survival data analysis. Her major current collaborative work involves the studies with infant flu, text informatics, and cardiovascular disease. She is also working on developing double robust method for survey data with incomplete outcome, semiparametric method for receiver operating characteristic (ROC) curves, analytic and simulation method for missing data problem using maximum likelihood and multiple imputation methods. Dr. Chen will be helping on the design and analysis of studies, especially the studies with missing data. Her expertise in analysis of missing data will especially benefit observational data analyses in VICTR including those arising from the Vanderbilt DNA databank.

Leena Choi, Ph.D., Assistant Professor of Biostatistics, Department of Biostatistics (80% effort with salary), has experience in statistical consulting, clinical trials, bioequivalence, likelihood paradigm, Bayesian analysis, pharmacogenetics, and longitudinal data analysis. She also has experience in modeling complex biomedical data combining lab data and clinical data, modelling QT prolongation, and pharmacokinetic and pharmacodynamic (PK and PD) modeling. Her major current interest is statistical issues in gene-gene interaction and a variety of problems in statistical inference, along with pharmacologic modeling. She will be responsible for analysis of PK and PD data, experimental design of VICTR programs (especially in translational research), and VICTR data analyses involving complex nonlinear models.

Tatsuki Koyama, Ph.D., Assistant Professor of Biostatistics (20% effort, with salary), has experience in clinical trials, experimental design and statistical computing and graphics. His current research focuses on methodologies for flexible and adaptive phase II and III clinical trials. Dr. Koyama's responsibilities will include design and analysis of studies with novel adaptive procedures. He has been at Vanderbilt since 2003, and is a member of the Vanderbilt-Ingram Cancer Center. Dr. Koyama will be responsible for developing novel adaptive clinical trial designs and for moving modern experimental designs into everyday use.

Bonnie LaFleur, Ph.D., MPH, Assistant Professor of Biostatistics (10% effort, with salary). Dr. LaFleur has over thirteen years of experience in biostatistical consulting, and has collaborated on papers published in numerous scientific journals. Her research interests include permutation and nonparametric statistics, generalized linear models, and analysis of linear and nonlinear mixed models, and the application of these models to biologic data (specifically genomic analyses). Her responsibilities will include the promotion and dissemination of statistical methods for biomarker development and other biologic studies. She is also a member of the Vanderbilt-Ingram Cancer Center.

Chun Li, Ph.D., Assistant Professor of Biostatistics, also an investigator in the Center for Human Genetics Research (CHGR) at Vanderbilt University (25% effort with salary). Dr. Li has specialty training in statistical geneticist and is a biostatistician with expertise in general biostatistical analysis of a broad range of problems and in both linkage and association methods for discovering complex diseases genes. In addition to statistical method development for human genetics studies, he is currently working on genetics studies of autism, diabetes, diabetic retinopathy, breast cancer, and leishmaniasis. He will have primary responsibility for design, review, and analysis of studies involving statistical genetics and genetic epidemiology.

Lily Wang, Ph.D., Assistant Professor of Biostatistics, Department of Biostatistics (20% effort with salary), has experience in clinical trials, health services and outcomes research, survival analysis, repeated measures analysis, bioinformatics databases and microarrays data analysis. Her major interests are the analysis of repeated and correlated data from neuronal experiments; the design and analysis of microarrays data; and the development of statistical methods for protein structural prediction based on sequences data. She will be providing support for the design and analysis of clinical trials and gene expression array studies. Dr. Wang is also the Department of Biostatistics' liason with the Department of Biomedical Informatics and will coordinate activities of the two departments.

Theresa A. Scott, M.S., Biostatistician II (50% effort with salary), has been providing statistical support for the residents and physicians in the Department of Obstetrics and Gynecology for nearly two years. This support has included study design, sample size/power calculation and justification, data collection assistance and guidance, methods determination and analysis, and manuscript review and submission. Ms. Scott has an additional three years of both formal and informal biostatistical consulting experience prior to being at Vanderbilt. She also has extensive teaching and programming experience, which she uses to help other statisticians and clinical investigators learn the R statistical programming language. She runs a weekly "R Clinic", and provides a yearly introductory seminar series on the programming language. Ms. Scott also uses her extensive R programming experience in generating the statistical reports for the Data Safety and Monitoring Committee of a large clinical trial, working with Dr. Harrell. In addition to teaching R, she has also co-led several GCRC Research Skills Workshops. Ms. Scott's focus throughout all of her work is reproducible research and analysis, and improving data representation. Her major interest is the education of clinicians regarding key statistical concepts, good research habits, and the needed computer skills. Ms. Scott's responsibilities will include assisting the Ph.D. biostatisticians with data analysis and reporting, providing assistance to Biostatistics Clinics, and teaching and promoting the use of reproducible research methodology.

Angel An, M.S., Biostatistician II (50% effort with salary), has been providing statistical expertise for the Department of Clinical Pharmacology, Center of Patient and Professinal Advocacy (CPPA), and the Office of Research Support Service since August 2005. She has experience in the design and analysis of clinical trials, focusing on the medication-biomarker interaction study in cardiovascular disease. She is involved in the development of operations and procedures for the collection, editing, verification and management of patient complaint and hospital risk management data. She has also assisted the grant writing and publication of the Vanderbilt research integrity survey study, patient complaint and health policy study, hospital risk management report, and CPPA risk-cautious intervention evaluation project. Ms. An has an additional four years of working experience in time series, experimental design and predictive model building prior to being at Vanderbilt.

Cathy Jenkins, M.S., Biostatistician II (50% effort with salary), has been at Vanderbilt University since April 2005. She has used her extensive programming experience to assist PhD biostatisticians on a drug safety project geared towards developing new methods of analysis. In addition, she has co-led several GCRC Research Skills Workshops, one part of the department's daily biostatistics clinics. Ms. Jenkins role will include providing continued assistance to PhD biostatisticians in the design and analysis of studies as well as providing support at the Biostatistics Clinics.

Yanna Song, M.S., Biostatistician II, (50% effort with salary), has been providing statistical support for the Neurology Department, Orthopedic Trauma, Energy Balance Laboratory and Kennedy Center at Vanderbilt for nearly two years. Song has experience in clinical study design and analysis, analysis and reporting for Data Monitoring Committees, bioinformatics and statistical genetics. She has a broad interest in clinical trials, statistical modeling, Bayesian analysis, statistical computing, and statistical graphics. Ms Song will provide continued assistance to Ph.D. biostatisticians in all aspects of statistical work especially in analyzing data for VICTR projects. She will also manage the use of the Department of Biostatistic's twiki web server in serving and coordinating other CTSA Biostatistics Programs.

Svetlana K. Eden, M.S., Biostatistician II, (45% effort with salary), for more than two years has been providing assistance in data processing and analysis in two clinical trials. She has used her extensive programming skills in statistical computing, promoting reproducible analysis and research, developing graphical methods of data representation. Interested in developing new methods of viewing and analyzing statistical data. She will be assisting Ph.D. biostatisticians with statistical analysis, biostatistical review of protocols, statistical computing and graphics, and statistical reporting. She will also play an active role in assistant participants in the Biostatistics Clinics.

To be named Administrative Assistant III (100% effort with salary) to assist DBCRE faculty and staff statisticians and clinical research ethicists with the coordination of teaching, design, review, and Biostatistics Clinic activity. The assistant will manage the operational aspects of the Biostatistics Clinics and will provide administrative support for VICTR activity for the clinical research ethicists.

Jeff Horner, B.S. Computer Systems Analyst II (100% effort with salary) will be responsible for advanced data management processes used to derive statistical analysis files, web interfaces for data management systems, implementing web server statistical computing applications (using R) to assist collaborators (especially for sample size calculations and randomization lists), and for updating and securing computer systems and servers used by DBCRE biostatisticians. Mr. Horner is currently the Department of Biostatistics' IT interface person with the Department of Biomedical Informatics and will continue to bring continuity to the data management approaches used by both departments.

Research Ethics Program

All of the faculty in this program will participate in the Working Group on Innovative Research Design, conduct ethics clinics, and provide ethics consultation on protocols that present new and difficult challenges. They will be integrated into design and review processes for VICTR along with the biostatisticians.

Ellen Wright Clayton, M.D., J.D. Professor of Pediatrics, Professor of Law, Co-Director of the Center for Biomedical Ethics and Society (15% effort with salary), is an internationally recognized expert in research ethics, particularly in the areas of genetics and epidemiology. She chaired the CDC-NIH Working Group on Informed Consent for Use of Stored Tissue in Genetic Research, co-chaired the ELSI Working Group of the International HapMap Project, and consulted with the Council of International Organization of Medical Sciences in their most recent revision of their guidelines and with the Marshfield Clinic regarding its Personalized Medicine Project. She has published many articles and book chapters on research ethics and is widely sought after for speaking and for consultation throughout the United States and abroad.

Larry R. Churchill, Ph.D. Ann Geddes Stahlman Professor of Medical Ethics and Co-Director of the Center for Biomedical Ethics and Society (15% effort with salary) Dr. Churchill has an extensive background in the ethics of human subjects research, beginning with the publication of Physician-Patient/Investigator-Subject: Exploring the Logic and the Tension in The Journal of Medicine and Philosophy (Vol. 5, No. 3) in 1980. He has served on IRBs and Data Safety Monitoring Boards for both universities and private research and pharmaceutical firms, and has held NIH funding for studies on informed consent in gene transfer research since 1995. Churchillís writings on the therapeutic misconception and issues of benefit in early phase clinical trails have appeared in IRB, Journal of Law, Medicine and Ethics, Social Science and Medicine, Molecular Therapy and other journals and books.

Elizabeth Heitman, Ph.D. Associate Professor in the Center for Biomedical Ethics and Society (15% effort with salary) Dr. Heitman's work focuses on the cultural and religious aspects of medicine, biomedical science, and public health. Her current NIH and NSF funded research evaluates graduate and postgraduate education in research ethics and trainees' professional socialization. Dr. Heitman has written on ethics education, clinical ethics consultation and the role of institutional ethics committees (IECs) in clinical medicine and health policy, and cultural aspects of health and health care. She has provided ethical analysis and consultation in clinical and bench research as a member of the MD Anderson Cancer Center IRB, the IECs of several research hospitals, and Policy, Ethics, and Law Core of the Southeastern Regional Centers for Biodefense and Emerging Infections. Several, and the Data Safety Management Board of an NCI prevention trial in colon cancer.
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