Study Design


The CTSI Biostatistics, Epidemiology and Research Design Program (BERD) offers study design services for all proposed clinical and translational work, including grant applications. This is primarily a joint effort of the Department of Health Outcomes and Policy and the Department of Biostatistics, in association with the CTSI and the Departments of Epidemiology and Statistics.

We can help you set up your study in terms of refining your objectives into testable hypotheses, choosing a study design, providing you with a data analysis plan, and completing a sample size/power analysis. Although we do not get directly involved in data management, we work closely with you to ensure that your data will be compatible with the analytic needs of the study.

The primary goal of the CTSI BERD Program is research collaboration, not merely technical consultation. We welcome the opportunity to forge long-term collaborative arrangements with clinical and translational researchers where ultimately, we can contribute to research questions and develop new methodologies in your field. We are especially interested in helping promote research careers for young investigators.

Important Information

  1. For grant submissions involving the CTSI, be sure to contact Dr. Zou at least four weeks before your planned internal submission to the Division of Sponsored Research (usually six weeks before the due date at the agency). In exceptional circumstances, where this deadline cannot be met, we shall evaluate our participation on a case by case basis.
  2. For investigator initiated Clinical Research Center protocols: Unless your project has faculty support from one of the following – Department of Biostatistics, Department of Epidemiology, Department of Statistics, or Department of Health Outcomes and Policy – you must contact Dr. Zou prior to submitting your protocol to the CTSI for review and ultimate submission to the Scientific Advisory Committee. In some situations, this might be as simple as providing a biosketch and contact information for the individual who wrote the analytic research plan.


BERD has initiated monthly studios where up to 10 researches can join three BERD members for individualized discussion about upcoming research projects. These are held the third Wednesday of a month from 11:30 a.m. to 1 p.m. with lunch provided. One need not attend the entire session, but an RSVP should be made on a first-come, first-served basis to April Braxton at

Open Office Hours

BERD has initiated weekly open ofice hours where BERD accepts walk-ins once a week for basic questions and guidance. These are held every Monday, Wednesday, and Friday 2:00 p.m. to 3:00 p.m. in the CTRB RM 5212. No RSVP required. Operates on a first-come, first-served basis.

Charges for Study Design

Senior Consultant Analyst: Advanced statistical consulting services requiring a Ph.D.-level statistician, including randomized experiments, sequential analysis, and optimal designs. $200/hr

Student Analyst: Services requiring a Master’s level statistical analyst or statistical programmer can be obtained at a charge of $125 per hour. Student assignment would be made after approval by the BERD faculty.

Before beginning work, BERD will provide a cost estimate and verify funding with the principal investigator of the study. BERD biostatisticians and CTSI staff will be responsible for managing work flow to ensure timely delivery of services, drafting invoices to collect payment for those services and following up to ensure payment is received.

Note: Coverage for the first hour of meeting with BERD faculty can be obtained via a voucher.

Students, post-docs and other young faculty can apply for a voucher covering consulting support for up to 10 hours for Senior Consultant Analyst or up to 16 hours for a Student Analyst if they have no other support to pay for the charges. TRACTS, TL1 and KL2 scholars are especially encouraged to contact Dr. Zou.

Grant Work

If there is a substantial analytical component to the grant that involves biostatistical or epidemiological work, the PI’s grant must include appropriate funding for the data monitoring and analytical work. If the assigned analyst is not in one of the four participating departments, an NIH biosketch of the person assigned to do this work needs to be forwarded to Dr. Zou. Where BERD members are listed investigators on a grant, a support letter to the granting agency is available on request.

Role Assignment by FTE on the grant

  • 30%+ PI or Co-PI
  • 10%-29.9% Key Investigator or Co-PI
  • 5%-9.9% Co-Investigator or Key Investigator
  • <5% Consultant

Budget Note: There are modest surcharges that apply to participation in grants that vary from department to department. Contact the analytic investigator for more details.


Wei Xue

Additional Services of the CTSI BERD Program