1. Partnering with the Biostatistics Center: Getting the most from your consultation
Gayane Yenokyan, MD, MPH, PhD
Executive Director, Johns Hopkins Biostatistics Center
Department of Biostatistics

2. Outline
Biostatistics Center as a resource for biostatistics and data management support
Breadth and scope of our consultations
Tips to make the most from your consultation

3. Johns Hopkins Biostatistics Center (JHBC): Who We Are
The practice arm of the renowned Department of Biostatistics since 1997
Well-respected with a proven track record of collaborations
Broad expertise in biostatistics and data management
Coordinated team to provide comprehensive consulting in support of education, research and practice
Range of levels and scope of support

5. Mechanisms of Consultation
Clinical and translational research projects through the ICTR/Quantitative Methods Core
by faculty who have % effort
Fee-for-service (FFS) projects based on hourly rates
Internal
External
Level of effort on grants

6. Biostatistics Clinical and Translational Research (BCTR)
Quantitative Methods Core
Biostatistics Program / BCTR
Center for Clinical Trials and Evidence Synthesis
Computational Medicine
Computational Biology/Computational Genomics
Free biostatistics and data management support to research faculty and staff primarily appointed at JHU
Faculty and staff walk-in clinics ( ~ 30 minutes)
ICTR requests for limited consultations (up to 5 hours)

7. Faculty and Staff Walk-In Clinics
Available to JHU faculty and staff
Including Post-doctoral Fellows and Residents
20 – 30 minute consultations
Hours and locations:
The clinics are held in the School of Public Health, 615 N. Wolfe St.
Monday 1:00 p.m. - 2:00 p.m. (E3144)
Tuesday 1:00 p.m. - 2:00 p.m. (E3144)
Wednesday 11:00 a.m. - 12:00 p.m. (E3531)
Thursday :00 a.m. - 12:00 p.m. (E3142)

9. Biostatistics and Data Management ICTR Requests
Requests are assigned on rotating basis among MS / PhD BCTR faculty
Expect 3-5 days between placing a request and initial contact
Up to 5 free hours of biostatistics and data management help per project
Consulting by phone, , Skype, or in-person meetings

10. Biostatistics Consultation Focus I
Research study design and protocol development for clinical trials and observational studies
sample size calculations and power analysis
randomization (from simple to block to complex minimization/covariate-adaptive randomization algorithms)
sampling (e.g. nested, case-cohort, matched case-control studies)
statistical analysis plans
Statistical analysis and interpretation
conference abstracts/posters/presentations and manuscripts
interim/final analyses / stopping rules, DSMB reports,
predictive modeling, data mining and model validation

11. Biostatistics Consultation Focus II
Innovative/complex statistical methods
adaptive clinical designs
sensitivity analyses for missing data
wearable devices
Independent statistical reviews for manuscripts
response to reviewers
independent statistical reviews
Manuscript preparation and scientific report-writing
reproducible analysis and reports

12. Data Informatics Services Core (DISC)
Review of database design and data collection instruments
Developing custom data collection systems
Preparing data for analysis and reporting
multiple data sources
analytic datasets from raw data
data reconfiguration / formatting
Administering and providing access and support to the REDCap (Research Electronic Data Capture) web application

13. JHBC Impact, 2012-2017 ~ 170 walk-in clinic consults/year: 60%-SOM
~ 200 consult requests/year: 70%-SOM; Top departments: DOM, Anesthesiology/Critical Care Medicine, Neurology, Psychiatry, Radiology
Support for junior researchers: Asst Prof (24%), Postdocs (8%), Fellows (24%)
Would recommend service to others: 86-91% (3 surveys)
DISC: 300 REDCap research studies (2,100+ active users)
Publications / Awards: Over 400 publications, 12K+ citations, awards (teaching, distinguished papers / posters)

14. Suggested timeframes for your biostatistics consultation
Approach JHBC as early as possible!
Abstract Preparation: at least 1 month
New Proposal Development: at least 1 month
Re-submissions: at least 2 weeks to improve scores
Manuscript Development/Scientific Writing: 1 to 2 months
Manuscript Review: a minimum of 2 weeks
Data Analysis: depends on complexity of analysis /status of data

15. Getting the most from your biostatistics consultation: Sample Size
Well-defined specific aims and primary outcomes
Minimal practically/clinically meaningful difference
Preliminary/pilot data and/or relevant literature on the topic
Measures of variability on primary outcomes
Idea about maximum sample size given the available resources.
There will be several iterations of sample size – keep good communication with the biostatistician to manage expectations, deadlines and other important developments that affect the study

16. Getting the most from your biostatistics consultation: Data Analysis
Provide well-defined specific aims, primary outcomes, and study design description
Have a well-organized and documented dataset.
Clarify work expectations in advance:
Scope of work, deliverables
Statistical software preference (STATA, SAS, SPSS, R)
Timeline, any relevant deadlines

17. Contacts regarding BCTR/JHBC consultations
Administrative Questions:
Nita James
Program Coordinator
Office: (410)
Research / Scientific Questions:
Gayane Yenokyan
JHBC Executive Director
Office: