The Biostatistics and Study Design Program aims to promote the incisive use of biostatistics and data science in designing, implementing, and interpreting clinical and translational research studies at Johns Hopkins to maximize these studies’ rigor, validity, and impact, through robust statistical advice and opportunity for longer term collaboration.
The Biostatistics and Study Design Program is part of the Biostatistics, Bioinformatics, Epidemiology and Research Design (BERD) Core, the ICTR-affiliated biostatistics service organization which supports Johns Hopkins biomedical scientists engaged in clinical and translational (CT) research. The Biostatistics and Study Design Program is an integral part of the Johns Hopkins Biostatistics Center (JHBC), the practice arm of the world-renowned biostatistics department at the Bloomberg School of Public Health. JHBC’s well-coordinated team provides biostatistics and data management expertise to Johns Hopkins Medical Institutions (JHMI) and external organizations in support of research, education, and service.
Biostatistics consultations focus on research study design and protocol development (including sample size justification, randomization, sampling, development of statistical analysis plans), statistical analysis and interpretation, manuscript and report preparation, independent statistical reviews, fully automated and reproducible reports, advanced computing and innovative methods. World leaders in statistical biomarker development, clinical trial design, analysis of complex longitudinal, clustered and censored designs, and the analysis of electronic health records provide expertise where the need arises.
Data management consultations include reviews of database design and data collection instruments, development of custom data collection systems, preparing data for analysis and reporting (including extracting and merging data from multiple sources, creating analytic datasets from raw data, data reconfiguration and formatting), administration, access and support to the REDCap (Research Electronic Data Capture) web application, and programming and development of analyzable datasets from the EPIC electronic medical record database.
Discussing your project with a member of our program is strongly encouraged for all investigators who do not already have biostatistical support as part of their funded protocols.
How to Engage with Us: Process Flow
Visit the tabs below to learn more.
Free Services
In support of faculty-led clinical and translational research, we offer free virtual walk-in clinics totaling four hours per week for short questions that can be addressed within 20 to 30 minutes. For improved efficiency and ease of access to appropriate the expertise, these walk-in consultations are separated by statistical software.
Mondays 11:00 a.m. – 12:00 p.m. (Statistical software expertise: R)
Tuesdays 11:00 a.m. – 12:00 p.m. (Statistical software expertise: R/SAS)
Wednesdays 11:00 a.m. – 12:00 p.m. (Statistical software expertise: Stata)
Thursdays 11:00 a.m. – 12:00 p.m. (Statistical software expertise: Stata/SAS)
Check here for cancellations
Please note that only faculty Principal Investigators (PI) and their co-investigators (co-I’s) are eligible for this service. Students working on their dissertations are not eligible for these free clinics.
Sign up here one hour before the clinic’s standing time. The link is not active outside the 10-11:00 am time period on the days of the clinic.
The names of the first three sign-ups will be forwarded to the expert running the clinic on that day and an email confirmation will be sent to these three individuals. “Session-full” notices will be sent to others. The expert running the clinic will contact the researchers attending the virtual clinic through MS Teams at the respective times. We plan to provide an approximately 20-minute consultation per researcher.
The clinics are conducted using Teams. Be online and available in Teams and be on the lookout for Teams messages or emails from the consultant. If you are not available when contacted, the biostatistical consultation opportunity will go to the next researcher in line.
These service requests are meant to provide consultation and resources to the faculty-led clinical and translational research. The CTSA program which supports the ICTR particularly seeks projects to improve research efficiency and outcomes. As many other ICTR services, our program provides limited free services and a fee-for-service option for more comprehensive projects.
- Grant preparation / study design, including randomization design and sample size justification, review of database design for data collection, Statistical Analysis plan (note: when our faculty or staff are included in the grant, we can provide a letter of support, budget justification, and faculty biosketch) – up to 10 hours
- Statistical Advice/ review of the statistical approach / assistance with response to reviewers for manuscripts – up to 5 hours
- Statistical analysis projects, including data management / preparing data for analysis, data visualization, statistical analysis, abstract or manuscript development – up to 2 hours
Submit your request here.
For general study design/grant application/biostatistics methods inquiries, contact Gayane Yenokyan at [email protected].
For logistics and administrative questions, contact Erica Tunstall at [email protected].
Fee-for-Service Option
Fee-for-service option is available for extended consultations through the Johns Hopkins Biostatistics Center (JHBC).
JHBC is the applied arm of the world-renowned Department of Biostatistics. We partner with investigators on the scientific studies and projects across the entire research continuum from its inception to final reporting. As a federal service center, we provide the extended service using JHU-approved hourly rates.
Focus on research study design and protocol development (including sample size justification, randomization, sampling, development of statistical analysis plans), statistical analysis and interpretation, manuscript and report preparation, independent statistical reviews, fully automated and reproducible reports, including for DSMB, and advanced computing and innovative methods.
Includes reviews of database design and data collection instruments, programming and development of analyzable datasets from the EPIC electronic medical record database, development of custom data collection systems, preparing data for analysis and reporting (including extracting and merging data from multiple sources, creating analytic datasets from raw data, data reconfiguration and formatting), administration, access and support to the REDCap (Research Electronic Data Capture) web application.
Time Frames
Please contact the program as early as possible before your deadlines and with an awareness of the following guidelines:
As the deadline approaches, the likelihood that we can provide helpful statistical support diminishes. On a case by case basis, The Biostatistics Center may decline requests that are too close to the deadline to provide anything useful.
Once the staff assignment has been made to your ICTR service request, the consultant will contact the researcher (within 1 week) to set up an initial meeting.
Submit your request here.
We generally need at least one month to work on the scientific abstract. Ideally, we hope you will give us two months or more. This highly depends on how well-defined is the research question, the state and the availability of the data, and the complexity of the analyses. If the request is submitted less than one month before the deadline, we may be able to assist with some simple summary statistics, but projects already in the queue will need to be prioritized, and acceptance of the request cannot be guaranteed.
The program provides grant submission support to projects 6 to 8 weeks ahead of NIH or other funders’ grant submission deadlines, depending on the complexity of the support required in the study and the level of involvement required by the JHBC faculty for the preparation of the grant application. This timeline ensures there is enough time for the biostatistician or data manager to provide a meaningful contribution to the study design and planning by understanding the study objectives and working on the statistical aspects of the study. For shorter timelines, our consultant may be able to provide brief feedback. Requests for assistance without adequate lead time will not allow JHBC to help provide an effective submission.
The program requires a minimum of two weeks for manuscript reviews.
Upon submitting a service request, you should receive immediate confirmation of successful submission. A biostatistician from the program will contact you to schedule next steps within 5 business days.
Testimonials
As a research fellow at Johns Hopkins, I can wholeheartedly say I would not have been nearly as productive without the help of the ICTR Biostatistics Program. The biostatisticians are available to meet each week through one-on-one sessions, and they not only thoroughly address each of your questions/queries, but take the time to explain and teach their statistical methodology. With their assistance, I was able to complete several projects while learning when to use certain statistical tests and code for them in STATA. I very strongly recommend their services for anyone who needs help with statistics or coding.
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Speedy, informative, learned a lot. This is an incredibly valuable resource, especially for junior faculty who need to make the most out of smaller studies, and limited budgets!
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I liked that during the biostatistics consultations not only were solutions presented during consultation, but reasons why the solutions were appropriate was also shared. I felt like I learned a lot during the short sessions.
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The consultant is wonderful. She is friendly, professional and has been nothing short of amazing. I requested her to help with all our departmental projects and I have recommended her, specifically, multiple times.
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My consultant was very knowledgeable. He commended the work that I had already done on my own and offered assistance on the aspects that I needed help with. He was flexible and even met me at the hospital when I had a day that was too busy for me to make it to the SPH.
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I liked the meaningful discussion and guidance from my consultant. She listened carefully to our study needs and suggested appropriate study methods and interpretation. She is willing to help me meet deadlines.
Our partners include the Trial Advisor Program (TAP) and the Core for Clinical Research Data Acquisition (CCDA).