The Biostatistics Core provides comprehensive statistical consulting and analysis services to investigators at all stages of the research process.

Please Note: The initial first hour of consultation is supported by the College of Health Solutions (CHS) at no charge for CHS researchers and affiliates. The first hour of consultation is specifically for projects new to the Biostatistics Consultation Core and is designed to determine the researcher’s needs and assess the scope of the project. This effort is not designed to address general analysis questions and does not apply to ongoing research activity. As part of our long-term collaboration planning, consultants may take up to 1 hour to review any project-related documentation ahead of the initial consultation. Any time needed beyond this will be charged to the client.

An important function of the Biostatistics Consultation Core is to provide consultation to all investigators and co-investigators with grant preparation for research studies. The following policies and guidelines for new grant preparation will apply:

1. The biostatistician(s) will be given at least 8 weeks to work on the submission prior to its due date and will be involved in all aspects of study development, including, but not limited to, study design, determining measures and outcomes, sample size calculations and data analysis.
2. The biostatistician must review the final grant application prior to submission to ensure consistency in the design, analysis, and sample size consideration sections as well as ensuring that reasonable funds for statistical support are allocated in the event of funding.
3. The Biostatistics Consultation Core does not charge for assistance with grant preparation for College of Health Solutions affiliated researchers or academic/non-profit external clients if the statistician will be included in the grant proposal, whether as an investigator, co-investigator, or statistician and thus will be funded through the grant.
4. The level of commitment should be discussed and mutually agreed upon between the PI, the statistician, and the Biostatistics Consultation Core director.
5. Submitted grant budgets should include the following for future statistical services: (1) percent effort for one or more named statisticians from the Core, or (2) a budget allocation for statistical services to be paid based on current recharge hourly rates, or a combination thereof.

The Core will assist College of Health Solutions researchers and affiliates with data analysis and preparation of abstracts, papers, and presentations. The following policies and guidelines will apply:

1. The principal investigators (PI) and/or appropriate research staff will consult with one or more member(s) of the Core to assess the statistical needs of the project.
2. After the consultation, a biostatistician will draft a Scope of Work (SOW), to be provided to the investigator, which details the expectations of the work to be performed and will include:
   1. a. A description of the project
   2. b. A timeline, including estimated deadline(s)
   3. c. Estimates for hours and cost or expected % effort
   4. d. Agreed upon project deliverables (methods section write-up, tables, analysis description etc.)
   5. e. Expectation of authorship. Please see our guidelines on authorship below
   6. f. Hourly recharge rate or % effort
   7. g. Payment options
   8. h. Contact information for the NCC and of the investigator’s business manager or business office reference.
3. The biostatistician performing the analysis will be a co-author on the publication(s) related to the project to acknowledge the intellectual contribution to the work, appropriate. Please see our guidelines on authorship below.
4. Statistician co-authors will use their primary appointment affiliation on manuscripts and abstracts.
5. Co-authorship cannot be considered in lieu of compensation.
6. The statistician will be given at least 1 week to review any final drafts of an abstract or publication prior to submission or resubmission in order to ensure study and statistical integrity.

Biostatisticians can provide sample size and power analysis for grant proposals and for IRB applications. This service will have the same expectations as those for the standard data analysis projects described above.

Data submitted must be complete and in a format that requires no or minimal pre-processing and quality control (“cleaning”). If the data requires significant data management the time needed for the consultant to process the data for analysis will be charged to the client. In addition, the Core cannot accept data with personally identifiable information (PII) included. It is incumbent upon the researcher to remove any PII from the data before it is provided to the statistician. Failure to do so may result in a delay in the start of the project until this issue has been resolved.

Note: “Hiding” columns in Excel or any other database manager does not constitute removal. All columns and metadata with PII must be deleted/removed.

The Core will ensure that the project data is housed only on devices managed by ASU and will therefore abide by all information security protocols therein. The Core also assures that all data received will not be used for any purposes other than the work agreed upon, unless written authorization is received from the client to perform additional work.

If your study used the Biostatistics Consultation Core services for any part of the proposal, paper or presentation, please acknowledge the Core.

The Core requires that the statistician be offered authorship on publications involving biostatistical support if he or she meets the criteria set forth by the International Committee of Medical Journal Editors (ICMJE) as follows:

1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
2. Drafting the work or revising it critically for important intellectual content; AND
3. Final approval of the version to be published; AND
4. 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.

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.

Below are the service models and associated pay structures the Core offers:

1. Recharge/Fee-for-Service Model (Hourly Rate): Please refer to the CHS Biostatistics webpage. Registered College of Health Solutions students who pay ‘out of pocket’ will be charged the internal College of Health Solutions rate.
2. Grant Support Model: The goal of providing grant support at no cost is to cultivate a collaborative environment that will lead to successful grant applications. For grant applications that Core staff helps prepare and write, it is expected that the principal investigator will invite Core statistical analysts to be included for percentage effort as appropriate. Core involvement from the initial steps of the application helps ensure that study design, data analysis, and power analysis are appropriate and optimal, and increases the chances that the grant will be funded.

Please contact the Core as early as possible before your deadlines and with an awareness of the following guidelines:

1. You should schedule a meeting with a biostatistician as early as possible in the research process. It is important to note that most projects require at least 6 weeks’ notice prior to the requested final deadline for the Core staff to complete the required work effectively. If your project has an earlier deadline (i.e., less than 6 weeks from the date of the initial request for consultation), we still encourage you to make a consultation request, but please note that we may be unable to accommodate earlier deadlines. Projects, depending on the complexity, may range from a few hours to many months to complete so please plan ahead.
2. As deadlines approach, the likelihood that we can provide helpful statistical support diminishes. On a case-by-case basis, the Core may decline requests that are too close to the deadline to provide meaningful assistance.
3. Because there are always competing demands for statistical support, investigators are expected to work with Biostatistics Consultation Core so their deadlines can be met. Any timelines set for providing data and protocol drafts, or otherwise disseminating necessary information, must be strictly adhered to, or a revised timeline will need to be established.
4. It remains the responsibility of the investigator to ensure that all activities move forward according to the timeline required for the project. The Core will endeavor to satisfy the investigators’ needs, following the timelines and deadlines agreed upon in the SOW.

We understand that manuscripts developed with the assistance of the Biostatistics Consultation Core may require revisions after submission for publication. The need for revisions can be handled in one of several ways:

1. If the subscription or grant support model is active, necessary revisions are covered under the initial agreement regarding percentage effort.
2. If the subscription or grant support model is no longer active, or the original project agreement designated under the fee-for-service model has ended, then a new SOW must be enacted to cover the cost of the additional hours needed by the statistician to complete the necessary revisions and/or perform any additional analyses.

Graduate students are permitted to use the Biostatistics Consultation Core services. However, if a graduate student wishes to enter into a formal agreement to obtain data analysis assistance from a statistical consultant, the Core requires that the student’s primary faculty advisor contact the Biostatistics Consultation Core directly acknowledging awareness of the student’s choice to access our services for the purposes of their dissertation or thesis.

Note: We do not offer assistance with coursework or qualifying exams.

If you do not have funds available from extramural grants, we encourage you to seek funding from other sources or College Health Solutions project grants.

To schedule a consultation email bcinfo@asu.edu for questions or complete a request form for collaboration.

For further information, please contact the biostatistics Director: Din Chen. Email: dinchen@asu.edu.