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General Business Practices


Collaboration with a biostatistician typically provides higher quality reliable results that stand up to critical peer review.  We identify and address issues that are not always obvious to investigators.  Our goal is not only to ensure statistical rigor and appropriateness, but also to make sure that the results are understandable to the investigator. 

Biostatisticians vary in their areas of expertise.  Some focus on clinical trial design, analysis and oversight, while others concentrate on observational study methods, laboratory experimental design and analysis, or high dimensional studies (microarray, sequence data, etc.).

It is critical to involve our biostatisticians at the very beginning of your project.   Issues relating to sample size and power, design efficiencies, nuisance variables, randomization, blinding, intervention strategies, time lines, data collection and management should be addressed in the planning stage.
 
During this initial meeting the background and scope of the project are queried.  It is also very important that the type and level of statistical support be established: through a paid grant, an internal contract (MOU) or external contract, or direct hourly billing.  Usually there is not enough time during this initial meeting to work out all of the project details, but enough information should be presented so that a reasonable level of support can be estimated, and the appropriate team of biostatisticians can be identified. Collaboration is at its highest when there is good communication between the biostatistician and the investigator.  The biostatistician needs an accurate description of the project and how the data were generated, addressing such problems as data management and collection, missing values, protocol deviations, and endpoint definitions. However, we ask that all investigators coming for biostatistical support be willing to listen to alternatives. ​

Any manuscripts or reports generated from this project should acknowledge the participation of the biostatistician as a co-author if he/she has made a significant contribution to the project.  However, the biostatistician should not be associated with the research without his/her consent. 

Although it is preferable to have our biostatisticians involved in projects from the beginning, many times the investigator will contact the biostatistician after the data have been collected.  In these cases, we will suggest statistical methods based on how the project was designed and how the data were collected.  Often, a more appropriate method of analysis will be recommended if the investigator has already run preliminary analyses.  Our biostatisticians can also recommend methods that will be able to extract useful information from problematic data.  We also analyze data to provide information on future efficient and less biased designs.

Researchers, investigators, and clients are provided statistical services when we are supported through grants as FTE collaborators, written into departmental contracts (MOUs), written into external contracts, or billed directly for hourly projects.​


Grant Support                                                                                                                                                              

The majority of our funding comes from collaborative work on NIH grants. We have extensive experience in preparing P01s, R01s, and R21s.  Through collaboration with us, 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.
 

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.


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.

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 CCC or CCTS mechanisms. For all other grants, biostatistician time is compensated through hourly billing or a departmental MOU. 

Please contact us to discuss your grant proposal.



Manuscript Preparation                                                                                                                                             

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.

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.

The following definition of a scientific contribution is based on published guidelines by Robert A. Parker and Nancy G. Berman: "Criteria for Authorship for Statisticians in Medical Papers." Statistics in Medicine 17: 2289-2299 (1998).  They list the following as examples of scientific contribution:
  1. DESIGN
    • Substantive input into the overall design of the study and protocol development, which may be thought of as "thinking through the study"
    • Writing one or more sections of the research protocol or grant application (for example, data analysis and/or data management)
    • Overall critical review to sharpen a grant application before submission, without major substantive changes
    2. IMPLEMENTATION
    • Regular (ongoing) participation in study meetings with the other investigators
    • Implementation of data collection and data management activities
    • Advising only on specific issues when requested by the principal investigator

    3. ANALYSIS
    • Planning and directing the analyses. This is usually based on the analysis plan described in the grant but now includes exact model specification, resolution at decision points, etc.
    • Preparing written material summarizing the results of the analyses for the other investigators and/or preparing formal reports
    • Doing the analyses



Department Contracts (MOUs)                                                                                                                                  

To develop long-term collaborative relationships, we use a mechanism whereby departments can provide salary support for a team of biostatisticians. Adjustments are made annually for increases or decreases in effort. 
 
 
Hourly Projects                                                                                                                                                          

For small projects, hourly billing is available with the rate dependent on the level of statistical expertise required.  Please contact us for current rate information.

External Contracts:  Support is provided for external institutions or industry on a case-by-case contractual basis.