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Biostatistics and Study Design Program


The Biostatistics and Study Design Program provides study design, methodological, data science and statistical analysis consultations to clinical and translational (CT) researchers. We assure that CT researchers have access to robust biostatistical advice for their study development, planning, implementation, statistical analysis, and reporting, that can be connected to opportunities for longer term biostatistical collaboration.

Chat with Biostats May 23, 2024

Chat with Biostats
Towards Better Practices in Precision Medicine: Lessons from the JH-CROWN Registry
Thursday, May 23, 2024 | Noon- 1:00 pm
Register

This chat focuses on how to best work with electronic health record (EHR) data, as well as tools and practices to improve the transparency, flexibility, reproducibility, and productivity of precision medicine research based on experience with the JH-CROWN COVID-19 registry.

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The Biostatistics and Study Design Program is part of the Biostatistics, Bioinformatics, Epidemiology and Research Design (BERD) Core, a 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 applied 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, including for DSMB, and advanced computing and innovative methods.

Data management consultations include 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.

Our distinct features include:

  • A coordinated team of data managers/programmers and biostatisticians allows for continuity of service
  • We offer access to world-class biostatistics faculty experts and innovative methods
  • EPIC/EMR and “big data” experience makes us effective collaborators in clinical research
  • Our “workflow” programming approach emphasizes auditability and scientific reproducibility

Discussing your project with a member of our staff is strongly encouraged for all investigators who do not already have biostatistical support as part of their funded protocols.

Visit the tabs below to learn more.

Free Services

We offer free walk-in (currently, virtual) clinics totaling 3 hours per week for short questions that can be addressed within 20-30 minutes. For improved efficiency and ease of access to appropriate the expertise, these walk-in consultations are separated by statistical software: R, STATA and SAS (one hour per week for each). Please visit the Microsoft Teams Training Site at the regular standing clinic times:

Tuesdays 11:00 am- 12:00 pm (Statistical software expertise: R/SAS)
Wednesdays 11:00 am- 12:00 pm (Statistical software expertise: R/Python)
Thursdays 11:00 am- 12:00 pm (Statistical software expertise: STATA)

Check here for cancellations

We ask that researchers email [email protected] one hour prior to the standing clinic time. 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” clinic through MS Teams at the respective times. As usual, we plan to provide an approximately 20-minute consultation to each researcher.

Please, note that our biostatistics and data management team will continue to provide consultations initiated through the web portal. Everything except the consultation itself will continue to be managed via email. If necessary, the consultants will be in contact with the researchers to arrange the best time to meet using one of the university’s suggested on-line meeting platforms: MS Teams or Zoom.

The program provides up to 5 hours of free statistical and/or data management consultation (5 hours for each) per project freely to investigators who submit a service request.

Frequently Asked Questions

  • Study design, including sample size justification
  • Grant preparation and letter of support
  • Randomization algorithm development and implementation
  • Sampling and matching using existing database
  • Review of database design for data collection 
  • Data visualization tools
  • Review of the statistical approach / response to reviewers for manuscripts
  • Combining datasets from multiple sources
  • Data management / preparing data for analysis
  • Statistical analysis / reporting

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 Biostatistics Center 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.

Within 3-5 working days of receipt of a request, a consultant will be assigned and in contact with you to arrange an initial meeting.

Submit your request here.

The Center generally needs at least one month. Ideally, we hope you will give us two months or more. If it is less than one month before the deadline, we may be able to assist with some simple summary statistics; however we cannot guarantee more complicated analyses, such as multiple variable analyses.

The Center typically needs at least three weeks for new grant submissions. If it is a re-submission, we need at least two weeks to improve your score.

The Center requires a minimum of two weeks for manuscript reviews.

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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Jiangxia Wang 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 Kit Carson. Kit listened carefully to our study needs and suggested appropriate study methods and interpretation. Kit is willing to help me meet deadlines.

Events

January 18, 2023
Chat with Biostats
SlidesVideo

Article: An Introduction to Power and Sample Size Estimation

View the ICTR events calendar for additional events.