Guidelines for Grant Preparation

Members and staff of the Center for Biostatistics and Advanced Informatics can participate in grant development in numerous ways including:

assisting with the development of a research team
assisting the investigators in refining and defining study aims and outcomes
developing study and experimental designs
writing statistical analysis plans
computing the sample sizes necessary to achieve the study aims
- We do not participate in proposals in which the investigator "only needs a sample size calculation" unless we have sufficient time to participate in the study design, because we almost never find that the sample size is as important as making improvements in the fundamental study design.

Required Timelines for Grant Preparation

The strongest grant proposals are those in which the proposal team is assembled at least four months before submission. Holding team meetings every three weeks or more often and having at least two major revisions of the proposal are optimal. When biostatisticians have sufficient time to do their best jobs, the likelihood of funding is significantly enhanced.

With rare exception we cannot provide assistance with proposals without two or more months advance notice. There are exceptions for cases involving resubmissions, renewals, or submissions of proposals that are substantially similar to previous grants in which the biostatisticians fully participated. On rare occasions we can analyze simple pilot datasets or perform sample size calculations when the design is very simple.

Use of Biostatisticians' Names on Proposal

We do not allow an investigator to use the name of a PhD or MS biostatistician on a grant or contract proposal unless the biostatistician has fully participated in the development of the proposal and can vouch for the study design and analysis plan.

Percent Efforts

It is the Center’s policy that percent efforts of statisticians on grant proposals reflect anticipated actual efforts. The minimum percent effort is generally 10% for clinical studies and 5% for basic science studies for faculty biostatisticians. The staff needs are negotiated on a project basis and approved by the Director or Associate Director. In certain circumstances biostatisticians can participate on grant applications as a consultant or be paid a fixed dollar amount or for a fixed number of hours on a grant proposal unless the granting agency disallows funding percent efforts. On the average, a grant is best served by having both a PhD and an MS biostatistician on the team, with the ratio of MS:PhD percent efforts being about 2.5:1.

Some factors that necessitate higher percent efforts are:

many variables per subject or animal
repeated measurements per animal or subject
a significant number of subjects dropping out before the planned termination of their follow-up
other types of missing data
plans for sequential monitoring or interim analysis of treatment effects or safety
providing reports for data and safety monitoring committees
receiving and merging data from other sources
multi-site studies
outcome and/or covariates that are only partially observable

Who to Contact

Unless the proposal is a renewal or resubmission (in which case you should contact the biostatisticians currently involved in the project), all requests for assistance on proposals must go to Holly Smith, Associate Director. To determine if the proposal development is already assigned to a member and/or staff of the Center, contact Holly Smith.

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