Donna Niedzwiecki, PhD

Director | Professor Biostatistics and Bioinformatics

Samantha Thomas, MS




The Biostatistics Shared Resource supports the clinical, translational, and scientific research needs of the Duke Cancer Institute (DCI) with respect to study design, conceptualization of research projects, analytic methods sections of grants and protocols, scientific review of protocols, participation in the DSMP, case report form (CRF) design, analysis for manuscripts and abstracts, data management, and other critical research activities.

These efforts are aligned with the DCI disease groups, with faculty and staff from the Department of Biostatistics and Bioinformatics partnering with disease groups, participating in research developmental meetings, and providing research methodological leadership to these efforts. The result of these alignments has been strengthened grant funding, high impact publications, and an enhanced research-training environment at DCI.


Biostatistics Organizational Chart


  • Access to state-of-the-art expertise in biostatistics methods for study design, analysis, and reporting
  • Partnerships in disease-specific clusters with embedded biostatistics teams providing ongoing development of research, grant applications, and clinical protocols
  • Participation and co-leadership in the development and testing of appropriate systems for trial data management and linkages through Medidata Rave, Medidata Balance, RedCap, and other tools
  • Assistance with compliance of clinical protocols through support of reporting, preparation of DSMB summaries, and participation in the DSMC meetings
  • Scientific review of all DCI protocols, service on the Cancer Protocol Committee (CPC) and the Safety Oversight Committee (SOC)


The Biostatistics Shared Resource members have numerous types of statistical computing software available for the analytic needs of the DCI. These include but are not limited to SAS, R, Stata, StatXact, nQuery, PASS, Medidata Rave, Rave Balance, S-Plus, Matlab, Maple, and Mathematica. Most are available through University-based site licensing or through Departmental-based group licenses. DCI supports Medidata Rave and Balance to facilitate clinical research.


The majority of the Biostatistics Shared Resource efforts are dependent upon computing and associated infrastructure. The computing hardware infrastructure of the Biostatistics Shared Resource is comprised of dedicated hardware owned and managed by the DCI Bioinformatics Shared Resource and is further extended by hardware resources maintained by DCI Information Systems (IS)Duke University Office of Information Technology (OIT) and by the Duke Clinical & Translational Science Institute (CTSI).

Accessing the Biostatistics Shared Resource

DCI members have direct access to the Biostatistics Shared Resource through participation in programmatic research meetings, by contacting their Program Leader, or by contacting the Core Managing Director. Biostatistics faculty and staff regularly participate in the disease group research meetings, according to their assigned alignments. This enables the Biostatistics faculty and staff to remain aware of research priorities, allows participation in discussion of research directions, and allows for the appropriate planning regarding protocols, grants, manuscripts, and projects. For new DCI members, if there is not an assigned contact person, or if there is a research direction that is not sufficiently supported, then meetings are arranged to discuss needs and appropriate staffing for the research area. The Biostatistics Director then determines required resources, and identifies personnel to assure that the needs are met, with approval of resources provided by DCI Administration.

Biostatistics Contact Information

Additional Resource

Clinical Trial Design Systems