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Biostatistics, Epidemiology and Research Design

Learn more about Biostatistics, Epidemiology and Research Design (BERD)

  • What's It All About
    The goal of the Biostatistics, Epidemiology and Research Design (BERD) component of the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS) is to provide integrated infrastructure for the design and conduct of research that is innovative and statistically sound, with an emphasis on studies in diverse populations. To achieve this goal, BERD will provide high quality methodological support to clinical and basic science investigators throughout the research lifecycle, integrating quality science and cutting-edge methodology. In collaboration with the Translational Workforce Development component, BERD will educate and certify investigators and their research staff to increase their knowledge and expertise in study design and research methods and will develop new methods and approaches to extend and improve BERD’s abilities to address the needs of translational research.
  • Who is Responsible

    Nawar M. Shara, PhD headshotDirector : Nawar M. Shara, PhD

    Director, Department of Biostatistics and Biomedical Informatics, MedStar Health Research Institute
    Associate Professor of Endocrinology, Georgetown University School of Medicine

    Dr Shara’s research focus includes Big Data solutions, Artificial Intelligence, Machine Learning, data visualization, Predictive Analytics, Adaptive Designs and Optimization schemes in clinical trials. She is a member of American Statistical Association, the Royal Statistical Society, the American Society of Nephrology, the Women in Statistics Caucus, ASA Scientific and Public Affairs Advisory Committee. She is the President of the National Arab American Medical Association (NAAMA DC Chapter) as well as the chair of the Science and Research Committee for NAAMA.  Dr Shara has served as a peer reviewer for the following journals:  Diabetes, American Journal of Cardiology and Journal of Community Hospital Internal Medicine Perspectives and has authored over 50 peer-reviewed journal publications.  Dr Shara served as Principal Investigator of several NIH-funded studies, National Kidney Foundation, Robert Wood Johnson Foundation. Her earlier work aimed at examining correlated of kidney and cardiovascular disease including oxidative Stress and surrogates of kidney function. She is currently the principal investigator of a NIH NCATS supplements looking to leverage voice activated technology (Alexa) to help patients with Heart Failure to better manage their disease. Dr Shara conducts, supports and oversees clinical and translational research across MedStar hospitals and is involved in teaching and education at Georgetown. Dr. Shara is the Chair for a session on AI in medicine at the First International Conference in Systems and Network Medicine at Georgetown University, Washington DC, September 2019. | Read More

    Photo of Dr. John Kwagyan sitting in an office chairCo-Director : John Kwagyan, PhD

    Director of Biostatistics, Clinical Research Unit, Howard University College of Medicine
    Graduate (Associate) Professor, Masters in Public Health Program, Howard University

    Dr. John Kwagyan is a research biostatistician and methodologist. He obtained his PhD in Statistics from Temple University and has additional training in computing from the Army High Performance Computing Center, University of Minnesota, Minneapolis. He also has training in bioinformatics at the National Center for Bioinformatics Technology at the National Institutes of Health.  His research interests include mathematical and statistical modeling of correlated data, survival and time-to-event models, statistical genetics, clinical trials, pharmacokinetic & pharmacodynamic modeling, and meta-analyses methodology.  Areas of application include clinical outcomes in minority populations. | Read More

    Mihriye Mete, PhD headshotBERD Team : Mihriye Mete, PhD

    Associate Director of Biostatistics, Department of Biostatistics and Biomedical Informatics, MedStar Health Research Institute (MHRI)
    Associate (Research) Professor, Department of Psychiatry, Georgetown University School of Medicine

    Dr. Mete, an expert in numerous statistical software applications including Stata, SPSS and R, specializes in quantitative research methods and study design. Her interdisciplinary background provides her with the ability to see the public health, policy, and socio-economic implications of clinical trials, enabling her to incorporate the most appropriate and scientifically sound study design and data analysis approaches. Dr. Mete has extensive collaboration experience and routinely assists researchers in the development and management of quantitative interdisciplinary research. Specifically, she develops proposals, analyzes data, and assists with manuscript preparation and submission. Because of the collaborative nature of her work, she has experience working with numerous investigators across a broad range of disciplines and has co-authored several peer-reviewed manuscripts. Her work has been widely published, in journals such as the Journal of the American Medical Association, Diabetes Care, and the Journal of Traumatic Stress. | Read More

    Alexander Libin, PhD headshotBERD Team : Alexander Libin, PhD

    Scientific Director of the Well-Being Literacy, Multimedia Education, & Psychosocial Research Program (WeLL), National MedStar Rehabilitation Network
    Associate Professor of Rehabilitation Medicine, Georgetown University Medical Center

    Dr. Libin is a psychosocial scientist and multimedia learning innovator investigating how critical thinking, ethical reasoning, and shared decision-making promote coping with life stressors in social networks, teams, and individuals. He conducts studies in CyberPsychology, digital culture and translational sciences exploring the impact of autonomous learning, health education, and digital technology, such as interactive multimedia and simulations, serious games and personal robotics, on well-being and psychosocial functioning across the life span. Vulnerable clinical populations including military veterans, persons with neurological disorders, chronic conditions and disability, children and the elderly are the focus of Dr. Libin’s research. Dr. Libin is an accomplished writer who has authored and co-authored 7 books, and provided editorship on 11 books, on the topics of visual literacy for self-management, coping with life stressors, understanding human differences and similarities, women’s well-being, cognition and learning styles, psychology of consciousness, empirical research on archetypes, and unified mental representation theory.  He has contributed to more than 150 book chapters, peer reviewed articles, and popular magazine articles in four languages (Russian, English, Spanish, and Japanese) covering the results of research findings and applied work in such areas as cyberanthropology, robotic psychology and robotherapy, role playing games as a learning tool for psychological literacy, person-centered psychosocial interventions, self-management and well-being, injury prevention, ethical dilemmas in clinical research, and patient – health care provider communication. Dr. Libin is a founding editor of Coping with Life Stress journal at Frontiers (Lausanne, Switzerland) and Post-traumatic Stress Disorder with Military Medical Research at BMC (Springer Nature).

  • Tell Me More

    Request Biostatistics and Data Management Support

    Clinical Research Informatics: Our data resource management services harness the power of the EHR to provide investigators and research groups with cohorts and data sets for prospective and retrospective studies, grant proposals, and chart reviews, as well as for clinical trial recruitment.

    Data Resource Management Services: The GHUCCTS Data Resource Management Services team helps investigators and research groups develop, execute, and manage data to allow for efficient and effective achievement of their research goals.

    Our data management services include the following:

    1. Production of a data management plan
    2. Secure online data storage for research projects and clinical trials
    3. Case report form/survey generation
    4. Data management consulting for best practices, including constructing metadata
    5. Data manipulation and transformation
    6. Data quality and assurance
    7. Data auditing
    8. REDCap

    EHR Data Access: The BERD Informatics analyst extracts EHR data from several platforms, encompassing the Inpatient, Ambulatory Care, Emergency Department, Operating Room, and Same-Day Surgery care delivery environments. The user interfaces for these systems range from intuitive Google-like interfaces to SQL databases which require the user to have experience in writing structured queries in Oracle, MS SQL, and MySQL. We leverage EHR data to provide investigators and research groups with cohorts for grant proposals, retrospective chart reviews, and clinical trial recruitment, as well as datasets for both retrospective and prospective analyses.

  • Resources

    Request Biostatistics and Data Management Support

    Please indicate the type of support you desire when submitting a request.

    Biostatistics and Biomedical Informatics Support

    Members of BERD are prepared to provide quality statistical assistance, biomedical informatics, and data resource management support to facilitate collaborations for a wide range of clinical and translational studies. The BERD team is experienced in designing studies, developing and conducting statistical analysis, and providing support for study designs, including long-term, prospective cohort studies, case-control studies using stored samples, cross-sectional surveys, randomized clinical trials, and chart reviews. BERD members are well versed in conducting sample size and power calculations, developing data analysis and quality assurance plans, and preparing abstracts and manuscripts. Additionally, the team possesses expertise in outcomes and health services research, including comparative effectiveness. 

    The BERD team provides cohort discovery, EMR extraction and data management services, which include creating study-specific databases using REDCap and/or other databases, building and overseeing data entry and management systems, archiving data for long-term storage, performing quality control for data collection and management, and managing and extracting data from EHRs (Cerner).

    BERD members have expertise and are qualified to provide the following:

    • Study design
    • Randomization
    • Sample size calculations and power analysis
    • Meta-analysis
    • Qualitative analysis
    • Econometric analysis
    • Spatial analysis
    • Numerical analysis and software development
    • Bioassays estimation
    • Statistical modeling of Big Data/data mining
    • Predictive modeling and risk scoring methods
    • Geospatial analysis
    • Comparative effectiveness
    • Multivariate analysis (factor analysis, structural equation modeling, path analysis)


    BERD provides training and educational sessions in specialized topics in statistical methodology, epidemiology, data resource management, and Big Data analytics. These sessions are prepared as needed and will be made available regularly.


    Members of the BERD will work with other GHUCCTS components to strengthen the quality of research through training and mentoring of new and existing clinical investigators in biostatistics and experimental design, including population-based research methods. Members of the BERD will provide mentoring to ensure that junior trainees can easily access the component both for educational resources and also as they begin to initiate projects and analyze data. The BERD members support junior investigators by offering unique resources and opportunities that will promote studies in, and investigators from, underserved populations by providing data from different sources, including databases available to BERD (see listing below), EHR, and publicly available data (e.g., CMS, BRFSS, NIS, and SEER). BERD members will provide specific methods and techniques necessary to access databases in special populations.

    View available databases