Biostatistics and Clinical Outcomes

The Biostatistics and Clinical Outcomes group provides statistical collaboration with investigators in the Department of Anesthesiology for research projects in the areas of clinical, genomic, and basic science research. We play a critical role in many key areas of a research project, including study design, data management, data analysis, scientific interpretation of the results, and preparation of the manuscript for publication. We also participate in the development of study protocols and grant proposals helping investigators to formulate research ideas, analytic strategies, and power estimates for achieving study objectives. Our mission is to promote research of the highest quality by encouraging application of sound statistical principles, conducting accurate and reproducible data analysis, and developing productive collaborations with investigators and all other members of the research team. We encourage investigators to schedule an initial meeting during the project planning stage or before the collection of the data so that statistical consideration can be taken into account earlier. We also strongly encourage investigators to have their data ready for analysis at least four weeks before the deadline if applicable.

Statisticians and Expertise

Our statisticians provide expertise on many aspects of statistical study design and analysis that are crucial to the success of a research project. Our team has extensive experience in analyzing clinical, genomic, and basic science data using a wide array of contemporary analysis methods involving statistical modeling, hypothesis testing, and parameter estimation. We also assist investigators in troubleshooting problems that may arise through the course of the study and in the interpretation of the results. The Biostatistics and Clinical Outcomes Group is directed by Dr. Yi-Ju Li, whose research areas are in statistical method development and applications for genetic and genomic studies of human complex diseases. Throughout her academic career, she has also worked on many clinical projects that are more biostatistics centered. In addition to her leadership role in the group, she and her postdoctoral fellow, Dr. Wenjing Qi, lead the genetic/genomic projects in our group. Ms. Mary Cooter, a biostatistician, was trained in biostatistics with strong theoretical and applied statistical knowledge. She has multiple years of experience in applied research of clinical outcomes modeling, longitudinal and correlated data methods, and methods for observational studies. Mr. Matthew Fuller has a Master degree in Statistics. His training has covered classical statistical theory and modern statistical methods for high dimensional data including machine learning for data science applications.

Meet the Team

Yi-Ju Li, PhD

Yi-Ju Li, PhD
Program Leader
Associate Professor

Mary Cooter, MS

Mary Cooter, MS
Biostatistician III

Default Doctor

Matthew Fuller
Biostatistician II

Wenjing Qi, PhD

Wenjing Qi, PhD
Postdoctoral Associate

What We Offer

  • Provide office hours for initial consultation, preferable during the study planning stage or prior to data collection.
  • Provide expertise in all aspects of study design, power calculation, database development, and statistical analysis planning.
  • Participate in protocol development for IRB submission.
  • Collaborate in grant proposal development for grant submission.
  • Outline statistical analysis plan (SAP) for transparency and documentation of the analysis strategy.
  • Collaborate in manuscript development and publication, particularly the description of statistical methods and presentation of the results.
  • Collaborate in conference abstract/paper submission and presentation.
  • Provide statistical education to clinical trainee and investigators through one-on-one exchanges during the work of each project as well as statistical lectures to provided continuing education opportunities to all members of the Department of Anesthesiology.
  • Participate in Data Safety and Monitoring Boards for clinical trial study protocol within the Department of Anesthesiology.

Research Program

Our members are closely connected with many clinical or basic research projects within the Anesthesiology department. Effective collaboration requires critical evaluation and appropriate application of contemporary statistical methods. We emphasize constant learning of new statistical methodology and software as well as new method development motivated by research projects that we are involved. Areas of interests include applications of factor analysis to postoperative cognitive data, methods for missing data, survival analysis for time-to-event data, genetic association methods for quantitative traits, and multiple traits, feature identification and classification in high-dimensional data such as microarray, proteomic, and metabolomics data.


The Biostatistics and Clinical Outcomes group strives to promote a greater understanding of statistical principles, and to conduct high quality data management and analysis that lead to high quality translational research at Duke. We will continue to improve the workflow on project prioritization and progress tracking, and continue to emphasize the documentation of our work to ensure the reproducibility of the research project. All final analysis data sets and computer scripts will be secured in a central location as the way of following the guideline of Duke’s translational medicine quality framework.

As research within Duke Anesthesiology advances, this group will continue to apply their complementary mix of quantitative skills and strong commitment to effective collaboration to ensure the department’s statistical needs are met. They look forward to productive collaborations on challenging research initiatives.

Yi-Ju Li, PhD

Yi-Ju Li, PhD

Program Leader
Associate Professor
Department of Anesthesiology
Department of Biostatistics and Bioinformatics
Duke Molecular Physiology Institute
Office: 919-684-0604

How to contact us?

Office hour request or general questions: Please send an email to

Request Statistical support: Please follow these steps: (1) log in departmental Staff Intranet and click “Information Request START HERE”, which will take you to a Duke Box folder; (2) review the documents that may be relevant to your request; (3) submit your request by clicking on “Create New Information Request,” which will take you to the qualtrics survey site.

Chris KeithBiostatistics and Clinical Outcomes