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Biostatistics Core
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  • Augusta University
  • Georgia Cancer Center
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  • Shared Resources
  • Biostatistics Core

Biostatistics Core

Biostatistics core (BC) is dedicated to supporting members of The Georgia Cancer Center in their investigative studies. Researchers will find expertise in planning, conducting, analyzing and reporting data 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.

Our Mission

Is to provide collaborative support in all areas of Biostatistics work that include, study design, analysis, and interpretation with 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. In all, we aim to ensure scientifically sound research.

Jump to: Services & Activities Equip.& InstrumentationGrant Prep & Review Manuscript Prep Pricing SupportWork Priorities & UsersContact

Contact Us

Bioinformatics Core

 Health Sciences Campus

GCC - M. Bert Storey Research Building

1410 Laney Walker Boulevard, Augusta, GA

CN-3112

General Services & Activities

  • Consultation in quantitative research in collaboration with scientists across basic, population, and clinical sciences, engaged in the planning, conduct and interpretation of research.
  • Statistical needs for cancer researchers related to protocol design, analysis, analysis of clinical trials and finding interpretations, In addition to interaction with sponsors and regulatory agencies.
  • Statistical needs for non-intervention studies in basic and population sciences.
  • Organize educational programs for research, clinical faculty, residents, and fellows.
  • Collaborate with investigators in study development, implementation, and publication by providing assistance with study design, statistical analysis plans, sample size and power considerations, statistical analysis, and grant and manuscript preparation.
  • Statistical programming and light data management
  • Data mining of SEER and GCC registry database as well as other national databases for hypotheses generation and answering scientific inquires by researchers.

Equipment & Instrumentation

Each Core member is provided with a laptop or a desktop with the processing speed and storage space (including external hard drives) required to accomplish all statistical and tasks. Shared and individual printers, fax machines, copiers, and scanners are provided by the GCC.  The Biostatistics core has access to all facilities at GCC. Including Local Area Network (LAN), with a dedicated manager, encompassing personal computers, file servers, printer servers, and other shared peripherals. Individual computers are managed centrally for software updates and network security. The scientific software licensed include SAS, STATA, PASS2024, NCSS2024, SPSS. A variety of open source software (e.g., R) for scientific computing is also widely used.

Grant Preparation & Review

The Biostatistics Core (BC) provides in-depth biostatistical review of the Georgia Cancer Center grants, providing important feedback regarding feasibility and statistical considerations in the proposals to both the review panels and investigators. 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 review of  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 publication.

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. Small grants typically require at least one month of collaboration prior to submission. Large grants such as PPGs require at least three months of intense collaboration before the submission guideline. Requests made closer in time to the deadline will be addressed only after work has been completed on grants that were submitted by investigators in a timely manner. Note that 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. For all other grants, biostatistician time is compensated through hourly billing.  Please see the charge chart.

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. 

 

Statistical Software

SAS, R, NCSS/PASS, STATA, STATISTICA, SPSS, nQuery.

Pricing Structure

First hour consultation is free. After initial consultation, fees are billed directly to the investigator’s unit/department via iLab

Please utilize iLab of the GCC Biostatistics Core to initiate and/or pay for the service.

Grant preparation support is offered to Georgia Cancer Center researchers free of charge, provided that Biostatistics core member assumes the role of co-investigator with funding request for significant percentage effort.

The following charge structure will apply:

Cancer Center Investigators : 100/Hr. |  External Clients in AU:  $200/Hr.

For Clinical trials, $150 per hour charge will apply.  Structured charges for clinical trials (CT) funded by industry  are per the entire CT:

  •  $10,000 at the protocol development for literature review, power analyses, objective formation, and Statistical Analysis Plan (SAP).
  •  $2,500 per quarter for interim analyses, CRF review, regulatory agency interaction, periodic reports.
  • $10,000 end of the trial for analysis, reporting, and publications.

Service

Internal ($)

External ($)

External Commercial ($)

 

Clinical Trial

Non- CT

Clinical Trial

Non CT

 

Data Analysis

150

100

150

150

200

Phase I CT

20k

 

25k

 

30k

Phase II CT

35k

 

40k

 

45k

Phase I/II CT

40k

 

50k

 

60k

Protocol Development

150

 

150

 

200

CT consult

150

 

200

 

250

Programming

 

100

 

100

100

 

  • For Phase I, II, I/II clinical trials, the charges are for the whole aspects of the trial from design to final reporting.
  • 50% discount for students, fellows, and residents
  • Waiving of fees is possible if the GCC director approves

Initiating Support

  1. If you are a fellow or a resident, please fill out the statistical support form and email it to Rsadek@augusta.edu. A meeting should be arranged to discuss the research project plan for the work to be performed.
  2. For Grant application by Investigators
    • Please allow at least two week before the deadline of a small grant and a minimum of three weeks prior to the deadline of large grants.
    • Make arrangement to discuss the aims, nature of the study, timeline, and outcomes.
  3. For Investigator initiated Clinical Trials
    • Please send a draft protocol or trial concept sheet, or synopsis.
    • Arrange for a meeting with the BC to discuss design, objective and endpoints, effect size and success criteria.

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 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 and have the discussion outlined in point b above.

  1. For other consultation
    • Please email and request a meeting with BC director.
  2. In general, initial consultation (up-to one hour) will be free.

GCC Biostatistics core iLab

Work Priorities & Requirements of Users

In general, the priorities for statistical work (from highest to lowest) are:

  • Grant proposal preparation
  • Abstracts for national and international meetings*
  • Clinical protocol design and review
  • Laboratory, animal, and epidemiology study design and review
  • Short term consults
  • Study monitoring, analysis, manuscript preparation, and replies to manuscript reviews
  • Education of users

Please note that the Core will only work on analysis for an abstract presentation at a national or international meeting if the Core worked on and/or reviewed the abstract submission (before the abstract was submitted).

Contact

photo of Ramses F. Sadek, PhD

Ramses F. Sadek, PhD

  • Professor of Biostatistics
  • Biostatistics Core Director, GCC
  • MCG, Augusta University

rsadek@augusta.edu

Reducing the Burden

The Georgia Cancer Center at Augusta University is dedicated to reducing the burden of cancer in Georgia and across the globe through superior care, innovation, and education. Through unprecedented expansion, the Georgia Cancer Center is providing access to more first-in-the-nation clinical trials, world-renowned experts and life-saving options.

Education & Research

M. Bert Storey Research
706-721-0570
cancer@augusta.edu

Care & Treatment

Outpatient Services Clinic
706-721-6744
https://www.wellstar.org/

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