Biostatistics Consultation Core

Initial assessment

Clients may schedule a 30-minutes appointment for statistical guidance and assessment of your project needs.

Follow-up Consulting

Consulting Fees*

The mentioned rates pertain to Long Term Consulting projects and may be subject to modification. This rate information is supplied solely for reference in approximating the cost of your consulting project. All rates are stated on an hourly basis. If necessary, a more detailed timeline, cost analysis, and estimate will be furnished after the initial meeting.

*If a faculty member of the core has been listed as co-PI, the payment might change to % effort

Research assistance

The core offers thorough statistical consulting and analysis services to researchers at every phase of the research process.

Grant preparation

One vital role of the Biostatistics Consultation Core is to offer guidance to investigators and co-investigators during grant preparation for research studies. The policies and guidelines outlined below are applicable to the process of preparing new grants:

1.     The biostatistician(s) will be provided a few weeks to engage in the preparation of the submission before the due date. Their involvement will span all facets of study development, encompassing study design, determination of measures and outcomes, sample size calculations, and data analysis.

2.     Before submission, the biostatistician is required to review the final grant application to ensure coherence in the design, analysis, and sample size consideration sections. Additionally, they need to verify that adequate funds for statistical support are allocated in case of funding.

3.     For UMD affiliated researchers or academic/non-profit external clients, the Biostatistics Consultation Core extends assistance with grant preparation with charge. This applies when the statistician is included in the grant proposal, whether as an investigator, co-investigator, or statistician, and will consequently be funded through the grant.

4.     The commitment level should be mutually discussed and agreed upon by the Principal Investigator (PI), the statistician (co-PI), and the Biostatistics Consultation Core director.

5.     Grant budgets submitted should outline future statistical services by specifying either (1) the percentage effort for one or more named statisticians from the Core, or (2) a budget allocation for statistical services based on current recharge hourly rates, or a combination of both.

Data analytics and abstract, manuscript and presentation preparation

The core is dedicated to aiding researchers and affiliates in data analysis as well as the preparation of abstracts, papers, and presentations. The following policies and guidelines will be applicable:

1.     The principal investigators (PI) and/or relevant research staff will engage in consultations with one or more core members to evaluate the statistical requirements of the project.

2.     Following the consultation, a biostatistician will create a Scope of Work (SOW) outlining the expected work. This document, provided to the investigator, will include:

• A description of the project
• A timeline, including estimated deadline(s)
•  Estimates for hours and cost or expected % effort
• Agreed upon project deliverables (methods section write-up, tables, analysis description etc.)
•  Expectation of authorship. Please see our guidelines on authorship below
• Hourly recharge rate or % effort
•  Payment options
•  Contact information of the investigator’s business manager or business office reference.

3.     The biostatistician conducting the analysis may be listed as a co-author on related publications to acknowledge their intellectual contribution, as per our authorship guidelines.

4.     Statistician co-authors will use their primary appointment affiliation on manuscripts and abstracts.

5.     Co-authorship is not a substitute for compensation.

6.     Statisticians will be provided  to review final drafts of abstracts or publications before submission or resubmission to ensure study and statistical integrity.

Power analysis

Biostatisticians are available to offer sample size and power analysis support for both grant proposals and Institutional Review Board (IRB) applications. This service aligns with the expectations outlined for standard data analysis projects mentioned earlier.

Data policy

Submitted data must be comprehensive and in a format requiring little to no pre-processing or quality control ("cleaning"). If substantial data management is necessary, the time spent by the consultant on processing the data for analysis will be billed to the client. Additionally, the Core cannot accept data containing personally identifiable information (PII). It is the responsibility of the researcher to eliminate any PII from the data before providing it to the statistician. Failure to do so might lead to a project delay until this matter is resolved.

Important: Merely "hiding" columns in Excel or any other database manager does not constitute removal. All columns and metadata containing PII must be deleted or removed.

The Core will ensure that project data is exclusively stored on devices managed by UMD, adhering to all information security protocols. Furthermore, the Core guarantees that any received data will only be used for the agreed-upon work, unless written authorization is obtained from the client for additional tasks.

Acknowledgement and authorship policy

If the Biostatistics Consultation Core services were utilized in any aspect of your proposal, paper, or presentation, kindly acknowledge the core.

The core stipulates that statisticians should be offered authorship on publications involving biostatistical support if they meet the criteria outlined by the International Committee of Medical Journal Editors (ICMJE), which includes:

·   Significant contributions to the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; AND

·   Involvement in drafting the work or critically revising it for important intellectual content; AND

·   Granting final approval of the version to be published; AND

·       Agreement to be responsible for all aspects of the work, ensuring thorough investigation and resolution of questions related to accuracy or integrity.

The services of the biostatisticians should be acknowledged in all publications and presentations if they made contributions to your project but do not meet the criteria for authorship. To avoid misunderstandings please discuss authorship early in your relationship with the statistician and include this information in the SOW. Note, the consulting statistician reserves the right to decline authorship when offered.

·   Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND

·   Drafting the work or revising it critically for important intellectual content; AND

·   Final approval of the version to be published; AND

·       Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Biostatisticians' contributions to projects should be acknowledged in all publications and presentations, even if they don't meet the criteria for authorship. To prevent misunderstandings, it is advisable to discuss authorship early in your collaboration with the statistician and include this information in the Statement of Work (SOW). It's important to note that the consulting statistician retains the right to decline authorship when it is offered.