Mission

Our mission is to provide collaborative support in all areas of Biostatistics work that include, study design, analysis, and interpretation that may involve interaction with industry, government, and regulatory agencies in the areas of Clinical trials, Epidemiology, laboratory studies, in addition to data mining using local and national databases for hypotheses generation and scientific investigation.

Overview

The Biostatistics Core (BC) is dedicated to supporting members of the Georgia Cancer Center in their investigative studies and clinical trials. Researchers will find expertise in planning, conducting, analyzing, and reporting, and designing studies relative to clinical trials as well as epidemiologic, and population-based studies.

The Biostatistics investigators also conduct independently sponsored research in statistical analysis, data mining using the Cancer Center registry data, clinical and laboratory, SEER and other national data bases. These studies can greatly benefit the work of Cancer Center members. Some biostatistics core are faculty at the department of Population Health Sciences and provide educational programs to meet the need of the GCC investigators.

Services and Activities

 

Contact Us

Biostatistics

Health Sciences Campus

Georgia Cancer Center - M. Bert Storey Research Building

Ramses F Sadek, PhD

Director, Biostatistics Core

CN-4151

(706) 721-6930

rsadek@augusta.edu

Grant Preparation and Support

The Biostatistics Core (BC) provides in-depth biostatistical review of Cancer Research Center grants, providing important feedback regarding feasibility and statistical considerations in the proposals to both the review panels and investigators. Through collaboration with the BC core in the development of grants and protocols, investigators quickly learn to value the expertise provided by our biostatisticians.

The strongest grants are those where a biostatistician has been involved from the beginning in the design. In general, the likelihood of funding is improved when a biostatistician has fully participated in the development of the proposal. We do not allow a biostatistician’s name to be placed on a grant unless they have been involved in its development or reviewed the grant application.

Grant Support Provided

To ensure the achievements of specific aims, biostatisticians provide critical design and methods support by:

  • Collaborating with the project investigators in the formulation of hypotheses and the design of experiments and clinical trials;
  • Providing assistance in developing and implementing data collection tools and data management systems to allow investigators to effectively and efficiently manage and analyze their data;
  • Conducting and directing the statistical analysis of data generated by the project investigators including both descriptive summary statistics and inferential methods;
  • Coordinating the development of new statistical methodologies, when needed, to directly support research issues that may arise; and
  • Providing clear presentations and discussions of results for publications.


Timing of Grant Support

Biostatisticians that are involved from the beginning need sufficient time to develop a strong grant for submission. The amount of time needed depends on the size of the grant and the agreed upon effort of the biostatistician. The earlier the support request, the more thorough and effective the level of biostatistical support will be, which in turn will increase the ability for your grant to impress critical reviewers.

Investigators should meet with the BC to discuss aims, measurements, criteria for success, and power and prior to any statistics work. Without full understanding of the work, no one can guarantee the quality of outcomes.

Percent Effort

Our policy is that the FTE (full time equivalent) should match the actual effort. Our minimum percent effort on a grant is 5%, although this percentage is rarely enough to cover the scope of the work in a typical grant. For applicable grants, time spent by the biostatistician preparing the grant itself is covered under the cancer center mechanisms.

Manuscript Preparation

Timing

Sufficient time is needed for the biostatistician to write or review the statistical methods and the results section of a manuscript or abstract. Whether the biostatistician writes or reviews these sections in a manuscript is determined by the level of collaboration. Thus, communication between the project investigator and the biostatistician is essential in order to meet specific deadlines. Generally two weeks are required for the biostatistician to write their section of the manuscript; however, four weeks may be needed for more complex analyses. Regardless, final versions of manuscripts and abstracts must be reviewed and approved before submission.

Authorship

Occasionally there is concern about whether or not the biostatistician should be a co-author on the manuscript. It is our policy that the biostatistician (both Ph.D. and M.S.) should be listed as a co-author if there has been a scientific or an intellectual contribution to the research and not be listed in the acknowledgments. If this is going to be an issue with the project investigator, then an agreement with the biostatistician on authorship of any resulting manuscripts should be decided during the initial phases of the project.

Initiating Support

Protocol design is an intensive collaborative work in which biostatisticians play a major role.

BC has the best in-house expertise of biostatistics support for trial design, protocol development, regulatory issues, analysis and reporting. Good protocol or proposal development takes in average of two months. The BC is not responsible for faulty design, methodology if the investigator is not willing to meet with the BC to discuss.

Residents

  • A meeting should be arranged to discuss the research project plan for the work to be performed.

 

For Grant application by Investigators

  1. Please allow at least one week before the deadline of a small grant and a minimum of two weeks prior to the deadline of large grants.
  2. Make arrangements to discuss the aims, nature of the study, timeline, and outcomes.

 

For Investigator initiated Clinical Trials

  1. Please send a draft protocol or trial concept sheet, or synopsis.
  2. Arrange for a meeting with the BC to discuss design, objective and endpoints, effect size and success criteria

 

For other consultation

  • Please email and request a meeting with BC director.

Meet The Team

photo of Ramses F. Sadek, PhD

Ramses F. Sadek, PhD

  • Director, Biostatistics Core

(706) 7216930

photo of Lifang Zhang, MD, MS

Lifang Zhang, MD, MS

  • Biostatistician & SAS Program Instructor

(706) 721-4453