A detailed “Guidelines for Estimating Biostatistician Effort and Resources on Grants” is available here as a PDF (PDF).
The CTSC Biostatistics and Study Design program is supported in part by funding from the CTSA NIH grant and the UC Davis School of Medicine. This funding allows us to provide some services without charge. Grant proposal preparation and analysis of preliminary data in support of grant applications receive highest priority for unfunded efforts. Grant proposals that require statistical assistance for preparation usually will require statistical services to accomplish the project goals; we will assist with preparing the budget to provide an appropriate level of statistical support. Additional information on estimating the level of effort for biostatistics required on grants is provided below.
For other biostatistical assistance (e.g., data analysis), unfunded support is limited to 10 hours and for medical residents and students 2 hours. For this level of effort, we can provide advice on appropriate statistical methods for data analysis, assist with interpreting the results, review draft manuscripts, assist with response to reviewer comments and consult on general statistical questions. Usually, this level of effort is not sufficient for us to be able to actually conduct statistical analyses except for simple, straight-forward projects. A “clean”, well-documented and structured data set is required if we conduct the statistical analyses. Detailed information on preparing your data for analysis is provided under the “Other Resources” heading. Beyond 10 hours, our standard recharge rate of $89/hour will be charged. All projects supported by extramural funding must provide salary cost recovery for professional statistical services at a level commensurate with the available funding and level of effort.
Successful investigators recognize the benefits of including statisticians as collaborators on their research projects. Statisticians help ensure that the study’s design is powerfully and cost-efficiently matched to study objectives, that necessary data to address those study objectives are collected and that appropriate statistical analyses are conducted and reported. These conditions are vital for successful research. In addition, biostatisticians have expertise in translating scientific hypotheses into actionable analyses and they also function as intellectual brokers who are exposed to, and contribute, innovative methods from a wide range of disciplines. Hence, they are well-poised to make substantial improvements in a proposal’s scientific aims and methods, both by identifying and correcting weaknesses and by spotting opportunities to apply and develop promising innovations from other fields. Early statistical collaboration thus leads to much better chances for a research proposal to be funded and for that research to lead to sustained and significant impacts. Within the headings that follow is guidance regarding the percent effort and the level of funding to allocate for biostatisticians on research projects. It is based on the collective experience of faculty and staff biostatisticians in the Division of Biostatistics. These guidelines should serve as a starting point for budget discussions. We strongly recommend that biostatisticians be actively involved throughout the grant proposal development and submission process, including the specification of research objectives and approach and proposal writing, as well as in budgetary decisions about biostatistician and programmer FTE, computer and software purchases, and scientific travel.
In general, funding for faculty and staff should not fall below 10% of total effort per statistician per time period on a single project. Although there occasionally are valid reasons for a lower level of effort on particular projects, intervals with funded effort falling below 10% require approval by the division chief for faculty and by the CTSC biostatistics director for CTSC staff. Funding should be matched to the size, scope and complexity of the data analysis and study design. Key determinants include the number of primary and derived study variables that will be collected and analyzed, the quality and completeness of the data to be supplied for analysis, and the complexity of the programming necessary to assemble input data and implement descriptive and analytical statistical methods.
- Large or complex projects: Total biostatistics FTE 50–100+%, such as 20% or more of Ph.D. biostatistician plus 30–100% of an MS biostatistician
High level of involvement in the development and implementation of the research project and communication of study results, which may take many forms, including:
- Development and/or implementation of complex study designs
- Assembly of datasets from large, complex or poorly documented administrative or survey databases
- Development and/or implementation of interim data analyses during data collection phase of prospective studies
- Coordination of analyses for multi-site projects.
- Development of and/or use and interpretation of novel or complex statistical methods
- Active participation in publications, with opportunity for first authored papers
- Regular Projects: Total biostatistics FTE 30–65%, such as 10–15% Ph.D. biostatistician plus 20–50% of an MS biostatistician.
This effort profile is suitable for straightforward projects with uncomplicated analyses.
- Active participation in publications, with opportunity for first authored papers
- Routine study design and analysis, e.g., analyses carried out using off-the-shelf procedures available in statistical software packages
- Involvement in study design, implementation and data collection
- Limited Scope Projects: Total biostatistics FTE 20–35%, such as 10–15% of PhD Biostatistician plus 10-20% of an MS biostatistician.
- Ongoing occasional consultations with PI about choice of statistical methods to use. This FTE level is typically too low for a Ph.D.-level biostatistician to carry out analyses
- This FTE level may be too low to support attendance at weekly or biweekly project meetings by the Ph.D. biostatistician.
- This level of effort commitment and support for the Ph.D. biostatistician is generally not compatible with smooth workflows and readily available consultation support, unless an experienced and capable M.S. biostatistician is supported on the project as well.
For multi-year projects, effort commitments may vary throughout the study timeline, according to the needs in various phases, including randomization schemes for sampling and experimental assignment (early), the development and implementation of data and safety monitoring plans (during the middle phases of prospective studies) and the implementation of statistical analyses and communication of study results (later).
- In general, biostatisticians help to develop proposals without compensation, including such aspects as calculation of samples sizes, analysis of preliminary data, and writing of statistical sections of grants, since it is assumed that the major biostatistical effort on the project will be via allocated funded effort post-award.
- There are some grant mechanisms that do not support funded effort by biostatisticians; this may include some K awards. In this case, the PI should discuss the proposal with the division chief or CTSC biostatistics director.
- Any changes in percent support made during proposal writing or after research has been funded must be made jointly between the PI and biostatisticians. If biostatistics percent efforts are reduced due to budget cuts, then the work of the biostatistician must also be reduced, and this requires consultation between the PI and the biostatisticians. Simply reducing sample sizes does not reduce the amount of work to do the analysis.
- Sometimes additional resources are required, such as computer hardware, specifically required software and travel. Please discuss this in advance.
- Letters of support are usually not needed if the letter writer is included as a funded investigator in the proposal, though we are happy to write one if it would be helpful. If the statistical support for the project will come from one of the CTSC faculty or statistical staff, and a letter is desired from CTSC Biostatistics program director, then we will be happy to provide one. With some exceptions, we usually will not write a letter of support if we do not have a defined role in the project. In general, biostatistical letters of support without accompanying biostatistical investigator funding is not a convincing component of a grant proposal. If the project needs statistics, a method of providing it should be in the proposal. If it does not, then a letter of support is usually not needed.
- Please notify us about the funding decision on the proposal, whether positive or negative. If the project is funded at a reduced amount, it may be appropriate to reduce the statistical support commensurately; it is rarely justifiable to reduce support by a much larger fraction than that. On rare occasions, investigators will re-budget upon the grant being awarded to eliminate statistical support. As one can imagine, this will considerably reduce our enthusiasm for future collaboration.