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 years at Vanderbilt's GCRC the number of GCRC publications has doubled. He will be Co-Director of DBCRE, responsible for quality improvement, researching research methods, and outcome metrics assessment within the program and with William Dupont, Ph.D. will direct biostatistics training for investigators. He will also be a leader in Biostatistics Clinics, will assist investigators with design and analysis, and will assist Dr. Harrell in the functioning of the Program.

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. Dr. Yu will be a Co-Director of DBCRE responsible for the biostatistical review component. Along with Leena Choi, Ph.D., he will oversee the design component of the program.

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, and for training of investigators along with Mr. Byrne.

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.

Leena Choi, Ph.D., Assistant Professor of Biostatistics, Department of Biostatistics (50% 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. Dr. Choi will also work with Dr. Yu to run the design component of DBCRE.

Tatsuki Koyama, Ph.D., Assistant Professor of Biostatistics (15% 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.

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.

Svetlana K. Eden, M.S., Biostatistician II, (63% 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 (50% 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 (50% 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 (10% 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 (10% 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 (5% 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.
Topic revision: r45 - 26 Apr 2013, JohnBock

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