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The Atrium Health Levine Cancer Institute (LCI) Department of Biostatistics and Data Sciences provides design, rigor and support for research projects whose goal is to identify and advance cancer therapeutics.

At its core, our work is about providing researchers with the results they need to better inform whether cancer treatments are working and should be continued, are not working and should be discontinued, or if a new form of treatment should be pursued – all with the goal of advancing outcomes so our patients can live their best lives.

Our team collaborates on cancer research in 4 ways:

  1. Biostatistics: We provide study design, sample size estimation, protocol development, statistical analysis, regulatory and compliance reporting, and manuscript and grant writing support to LCI investigators.
  2. Bioinformatics: We manage, process and analyze genomics big data to identify biomarkers for cancer diagnostics, therapeutics and prognosis.
  3. Quality Assurance Monitoring: We ensure protection of the rights, safety and well-being of clinical study participants and that study data are accurate, complete and reproducible per the study protocol, federal regulations, good clinical practices and local standard operating procedures.
  4. Observational Research Data Core: We collect real-world clinical data and patient-related outcomes from electronic health records, cancer registries and other data sources for observational studies in cancer research.

LCI Biostatistics

The LCI Biostatistics team collaborates with LCI researchers on investigator-initiated research (IIR), which includes clinical trials, observational studies, translational research, omics studies and health economics studies.

The Biostatistics team supports all phases of research, including the initial concept phase, development process, oversight phase, final analyses and ultimately the publication of results. Our biostatisticians:

  • Provide study design, sample size estimation, protocol development and statistical analysis
  • Collaborate with investigators on reporting for regulatory and funding entities, as well as manuscript and grant writing
  • Serve as co-investigators on research grants
  • Serve on the LCI Data and Safety Monitoring Committee and the LCI Protocol Review and Monitoring Committee
  • Provide formal biostatistics education at LCI and mentor junior investigators

Meet the Team

James Symanowski, PhD

Chair, LCI Department of Biostatistics and Data Sciences

James Symanowski

Chair, LCI Department of Biostatistics and Data Sciences

Wei Sha, PhD

Research Professor and Deputy Chair, LCI Department of Biostatistics and Data Sciences

Wei Sha

Research Professor and Deputy Chair, LCI Department of Biostatistics and Data Sciences

Levine Cancer Bioinformatics

The Levine Cancer Bioinformatics team collaborates with physicians, laboratory scientists and biostatisticians to provide expertise in genetics, genomics, bioinformatics and high-dimensional computations – all with the goal of identifying new biomarkers that can enhance therapeutics and precision oncology care at Levine Cancer.

The primary function of this team is to design and analyze genomics big data, including next-generation sequencing and epigenetics, to provide interpretable results and graphical visualizations for use in grant applications and research articles.

In addition, the Bioinformatics team works with Information and Analytics Services to develop and maintain a high-performance computing framework. This cutting-edge framework not only streamlines bioinformatics analysis, but also secures genomics big data, enhancing the reliability, capability and capacity of bioinformatics services and genomics data management for researchers across Levine Cancer.

 

Meet the Team

Hsih-Te (Paul) Yang, PhD

Senior Oncology Biostatistician and Bioinformatics Manager

Hsih-Te (Paul) Yang

Senior Oncology Biostatistician and Bioinformatics Manager

Levine Cancer Quality Assurance Monitoring

The Levine Cancer Quality Assurance (QA) team is responsible for ensuring patient safety and that the rights and well-being of all human subjects involved in research at Levine Cancer are protected.

The QA team ensures that reported trial data are accurate, complete and verifiable from source documents. The team also works with principal investigators, sponsor investigators and study teams to make sure they are adhering to all protocols, federal regulations, good clinical practices and local standards of practice.

The QA team conducts sponsor-required monitoring for all relevant Levine Cancer investigator-initiated studies, works with stakeholders to review protocols in the development of new studies and reviews data for Food and Drug Administration inspections or co-op audits.

Meet the Team

Cecilia Flynn, MS, CCRP

Senior Oncology Research Manager

Cecilia Flynn

Senior Oncology Research Manager

Levine Caner Observational Research Data Core

The Levine Cancer Observational Research Data Core (LORDC) team collects real-world clinical treatment and outcomes data from LC patients. This data provides a resource for sponsored investigators and biostatisticians to conduct observational research. The LORDC team includes systems engineers and data coordinators who extract, transfer, process, load and audit patients’ electronic health records and outcomes data from various sources into the LORDC database, a state-of-the-art web-based application that securely stores patients’ real-world clinical data and outcomes to be used for observational cancer research. The LORDC team also collaborates on protocol development, abstract preparation and manuscript writing.

Meet the Team

Rupali Bose, MS, MBA

Manager, Application Specialist

Rupali Bose

Manager, Application Specialist

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