Biostatistics and Clinical Outcomes

This group provides statistical collaboration with investigators in Duke Anesthesiology for research projects in the areas of clinical, genomic and basic science research. They 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. They also participate in the development of study protocols and grant proposals, helping investigators formulate research ideas, analytic strategies and power estimates for achieving study objectives.

The mission of the Biostatistics and Clinical Outcomes group 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. They use an online ticket track system to serve as a channel for project requests, communications and project tracking. Investigators are encouraged to 1) schedule an initial meeting during the project planning stage or before the collection of data so that statistical consideration can be taken into account early on and 2) have 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. They have 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. They 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, a statistical geneticist, whose research areas are in statistical method development and applications for genetic and genomic studies of human complex diseases. Through 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 within this group. 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. John Hunting, a biostatistician, was trained in epidemiology with a focus in biostatistics applications. He brought in the expertise in epidemiology study design and approaches to this group.

What We Offer

  • Provide office hours for initial consultation, preferably 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 trainees 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 Duke Anesthesiology.
  • Participate in data safety and monitoring boards for clinical trial study protocol within Duke Anesthesiology.

Research Program

Our members are closely connected with many clinical or basic research projects within Duke Anesthesiology. Effective collaboration requires critical evaluation and appropriate application of contemporary statistical methods. They emphasize constant learning of new statistical methodology and software as well as new method development motivated by research projects that they 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.

Goals

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. They will continue to improve the workflow on project prioritization and progress tracking, and continue to emphasize the documentation of their 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

Biostatisticians:

Mary Cooter, MS, Biostatistician II
John Hunting, MPH, Biostatistician II
Wenjing Qi, PhD, Postdoctoral Associate

How to contact us?

Office hour request or general questions: Please send an email to yiju.li@duke.edu.

Request Statistical support:

ChrisBiostatistics and Clinical Outcomes