Background and Rationale
Funding agencies, such as the National Institutes of Health (NIH), are committed to promoting rigorous and reproducible research in all areas of science. Biostatisticians play a crucial role in ensuring that studies are well-designed, high-quality research data are generated, sample sizes are sufficient to test the scientific hypotheses, methodologies are rigorous for addressing research questions, and findings are reported with accuracy and clarity. Moreover, biostatisticians often contribute to the innovation of research projects through the development of state-of-the-art tools and advanced analytical methods. Therefore, as indispensable members of team science, their contributions have been critical to the success of many projects. Early involvement of biostatisticians in a study often enhances the quality of research proposals and increases their likelihood of securing funding. On the other hand, adequate time and effort allocation, commensurate with the biostatisticians’ dedication, is essential to ensure the quality of biostatistical work and foster symbiotic, sustainable team collaborations. This document provides guidance on estimating the biostatistician effort and resources required for biostatisticians on projects, reflecting their contributions to the study design, data quality assurance, statistical analysis, and result interpretation. This guidance is developed based on input from department faculty and recommendations from peer institutions1.
Guidelines for Estimating Biostatistician Effort and Resources2
In general, except for limited scope projects, the combined effort of PhD and MS biostatisticians (or graduate assistants) should not fall below 10% on a project. Special cases need to be discussed with the department Chair.

Large or Complex Projects
Projects in this category include NIH P, U, large R01 grants and equivalent mechanisms from other institutions, which require a high level of involvement of biostatisticians in study design, data analysis, method development, and result dissemination. These projects require a high and sustained level of biostatistician involvement in the development and implementation of the research project, collection and analysis of data, and dissemination of results. Specific activities conducted by statisticians may include:
• Actively participating in study phases, including regular meeting attendance.
• Developing and/or implementing complex study designs.
• Developing data collection standards and performing minor data cleaning and validation. Data management (e.g., assembling, reviewing, cleaning, validating, and documenting datasets from various sources) may require additional effort.
• Developing and applying appropriate statistical methods to interim and final data analyses, possibly including novel method development and writing custom code for complex analyses.
• Ensuring reproducibility through well-documented and maintained code and data files.
• Summarizing and interpreting results, preparing internal reports, and collaborating on publications, potentially leading to first-authored papers.
Effort
Total biostatistics annual effort 50–100+% per year, such as 20% of a PhD biostatistician plus 50–100% of an MS biostatistician (or 1-2 graduate assistants).
Regular Projects
Projects in this category include NIH R01 grants and equivalent mechanisms from other institutions, which require a significant amount of biostatistics effort. These projects are commonly well-designed and straightforward projects with uncomplicated analyses using standard statistical methods. Well-documented primary data sets are assumed to be provided for statistical analyses such that minimal effort, if any, is needed on behalf of the biostatistician to clean and organize the data in preparation for statistical analyses. Specific activities conducted by statisticians may include:
• Actively participating in study phases, including regular meeting attendance.
• Implementing commonly used study designs and preparing statistical analysis plans for projects.
• Performing minor data cleaning and validation.
• Applying appropriate statistical methods to interim and final data analyses.
• Ensuring reproducibility through well-documented and maintained code and data files.
• Summarizing and interpreting results, preparing internal reports, and collaborating on publications.
Effort
Total biostatistics annual effort 35–70% per year, such as 10–20% of a PhD biostatistician plus 25–50% of an MS biostatistician (or 50%-100% of a graduate assistant).
Simple Projects
Projects in this category include NIH R21, R34 grants and equivalent mechanisms from other institutions, which require a small amount of biostatistics effort. These projects are simple projects requiring straightforward statistical analyses, resulting in about one manuscript per year. Clean, well-organized primary data sets are assumed to be available, requiring minimal effort for data review and cleaning by the statistician. Specific activities conducted by statisticians for simple projects may include:
• Meeting occasionally with PI to consult about study issues such as study design, data analysis and interpretation, or reporting.
• Conducting focused statistical analyses on cleaned and well-documented data using standard procedures available in statistical software packages.
• Ensuring reproducibility through well-documented and maintained code and data files.
• Summarizing and interpreting results, preparing internal reports, and collaborating on publications.
Effort
Total biostatistics effort of 20-35% per year, such as 5-10% of a PhD biostatistician plus 15-25% of an MS biostatistician (or 30-50% of a graduate assistant).
Limited Scope Projects
Projects in this category include NIH R03, K grants and equivalent mechanisms from other institutions, which require a minimal amount of biostatistics effort. This level of funding only supports limited meeting attendance and targeted consultation on study design, data analysis and interpretation, or reporting. This effort is not sufficient for the biostatistician to conduct analyses, but they may consult with a data analyst supported by the investigator’s project. Specific activities conducted by statisticians for simple projects may include:
• Limited meeting attendance with PI to consult about study issues such as study design, data analysis and interpretation, or reporting.
• Consulting with a data analyst supported by the investigator’s project
• Providing feedback on internal reports and publications.
Effort
Total biostatistics effort of 5-10% per year, such as 5-10% of a PhD biostatistician.
1Adopted from the University of California Davis School of Medicine Guidelines for Estimating Biostatistician Effort and Resource Guidelines on Grants and Northwestern University Feinberg School of Medicine Annualized Biostatistics Effort Allocation Guidelines. 2Effort allocation guidelines assume that other necessary resources such as research study coordinators and project coordinators are also included in the budget. If a project has a strong research study coordinator or team of coordinators, if may be possible for biostatistics effort to be on the lower end of the range provided (e.g., if the project coordinator sets up and maintains the study database with limited input from the biostatisticians). Notably, the biostatistics effort does not include data entry.