Institute for Clinical Research and Health Policy Studies

Biostatistics, Epidemiology, and Research Design (BERD) Center

The Biostatistics, Epidemiology, and Research Design (BERD) Center is a joint program between ICRHPS and Tufts Clinical and Translational Science Institute (Tufts CTSI). Statisticians in the BERD Center collaborate with clinical, health services, and basic science researchers throughout Tufts University and Tufts Medical Center and its affiliates. We seek to promote innovation and excellence across the spectrum of translational and patient-oriented research by working with our collaborators to plan and perform the most suitable analysis for the aims of each study. Pre-award proposal development services are available for free and post-award statistical analyses are handled through a consulting program.

BERD has a broad range of expertise in both standard and cutting-edge methods, as well as a history of developing and evaluating new methodology. We also provide training, education and study design support.

BERD serves as an academic center for biostatistics throughout the medical campus. Through weekly meetings and seminars, it provides a forum for the discussion of statistical topics, including new methods, as well as consulting strategies. Additionally, BERD members have opportunities for continuing education, both at local and national meetings.

BERD staff provides study design, data management, and statistical support for many different areas of clinical research including but not limited to, cardiology, emergency medicine, genetics, infectious disease, nephrology, nutrition, pediatrics, radiation/oncology, and rheumatology. Our projects span the spectrum of translational science, ranging from pre-clinical animal studies to clinical research, health services research, quality improvement programs, and community-based research.

Many of the consulting and collaborative projects BERD staff members work on result in the development of grants and/or publications in peer review journals. Statisticians in the BERD work with investigators typically through one of two mechanisms: (1) funded effort through grants or other institutions or (2) fee-for-service consulting.

Find a Statistician to Collaborate with on a Grant or Other Funded Project
Please contact Norma Terrin.

Find Out About Fee-for-Service Consulting and Our Rates
Please contact Robin Ruthazer.

Find Out About Drop-in Sessions
BERD offers a Drop-in Session every week. Stop by for help with clinical research questions.

What information will the statistician need before working on my study?

  • A brief description of the project is extremely helpful to the statistician. Be prepared to tell the statistician what your study aims and hypotheses are, what analyses you’re looking for, and be sure to describe the study design.
  • Sometimes it can be helpful to send your data to the statistician for review when you describe your study, but please make sure they know you will be sending it before you do so.
  • Before we can work on your project, we need confirmation that the study has approval from the Institutional Review Board (IRB).Verbal confirmation is sufficient.
  • Please de-identify all data before you send it to us. We cannot accept data that includes patient identifiers, such as medical record numbers or names, etc.

What format should my data be in?

  • Discuss this with your statistician. We often get datasets in MS-EXCEL or MS-ACCESS, but we can read data that come in many other formats as well.

How long will it take the statistician to do the work and how much will it cost?

  • After the statistician understands what type of work you need, he or she will give you an estimate of both the number of hours it might take to complete, and when the work might be done. If the actual work-time begins to exceed the estimate, the statistician will contact you for permission to continue on the project. The fee for the project depends both on the number of hours the statistician spends on the project and the type of work needed. Please contact us for our current rates.

If I pay for services, do I need to acknowledge the statistician in my publications?

Yes. If the statistician has substantially contributed to the project and final manuscript, he or she should be included as a coauthor. Many journals have guidelines about who should and should not be included as an author. Discuss consideration of authorship directly with the statistician you’re working with.

What is E2E?

The Institute for Clinical Research and Health Policy Studies (ICRHPS) at Tufts Medical Center is developing and piloting a new approach to clinical trial design called efficacy to effectiveness (E2E) trials. Efficacy trials assess treatments in optimally selected patients, under advantageous conditions, for short periods, for regulatory approval and marketing. Effectiveness trials test treatments across the spectrum of patients ultimately treated, in real-world conditions, with follow-up that matches durations of typical treatment. However effectiveness trials are often not performed, leading to lack of effectiveness and safety data for many new treatments. To address this issue, a study design was devised that integrates efficacy and effectiveness trials into a two-component “efficacy-to-effectiveness (E2E) trial.”1 With this approach, if the initial efficacy trial component is positive, then a seamlessly transition can be made to the effectiveness trial component, improving and accelerating the trial’s impact.

We invite Tufts CTSI investigators who are developing a clinical trial protocol to submit a request for E2E design consultation to the Biostatistics, Epidemiology and Research Design Center (BERD) as we continue to move this innovative idea from concept into practice. E2E Design Consultations are also available through the Johns Hopkins-Tufts Trial Innovation Center. The concept is being further developed in collaboration with MIT’s NEWDIGS (NEW Drug Development ParadIGmS) program. 

What is involved in an E2E Consultation?

An E2E Trial design ensures that the investigator thinks more broadly about the impact of their research and plans ahead to prospectively design a trial to provide both robust efficacy data as well as effectiveness data. This will allow patients, physicians, regulators and payers to make informed decisions and maximize generalizability and adoption of the new intervention into clinical practice. The investigator will work with the E2E core team at Tufts consisting of clinicians, trial design experts, regulators, biostatisticians, epidemiologists and healthcare economists to:

  • Identify different stakeholders in the drug development process and the evidence required by each party for the specific intervention.
  • Plan the transition from efficacy to effectiveness phase (endpoints, inclusion criteria, sample size calculations and statistical analysis plan, funding mechanism).

How to apply

For more information please go to and contact one of our statisticians or complete the online service request form. 

1 Selker HP, Oye KA, Eichler HG, Stockbridge NL, Mehta CR, Kaitin KI, McElwee NE, Honig PK, Erban JK, D’Agostino RB. A Proposal for integrated efficacy-to-effectiveness (E2E) clinical trials. Clinical Pharmacol Ther; 2014: 95(2) 147-153. 

BERD staff members hold faculty and scientific staff appointments at Tufts Medical Center and Tufts University School of Medicine. They mentor clinical fellows and teach courses in the Graduate School of Biomedical Sciences at Tufts University.

Our team members also serve nationally as consultants to institutions, foundations, federal agencies, and corporations as well as on grant proposal review panels of the National Institutes of Health and other funding agencies, as members of Data Safety and Monitoring Boards, and as reviewers and editors for a variety of scientific journals.

BERD staff members provide expertise in statistical modeling, including linear and logistic regression, survival analysis, analysis of longitudinal data, and spatial analysis of geographic data. We also provide predictive modeling, competing risks analysis, multi-state models, time series analysis, joint models for longitudinal and survival outcomes, meta-analysis, bioinformatics, analysis of genomic and genetic data, non-inferiority trials and analysis of complex survey designs through the BERD.

Staff Research Interests

Current research interests of the BERD staff include clinical predictive models, survey design, geographic and spatial analyses, bioinformatics, diagnostic tests based on biomarker data, treatment variability and the heterogeneity of treatment effect. Other interests include health-related quality of life, research in minority populations and analysis of community data, cognition, nutrition and teaching methods for biostatistics in medical settings. The BERD staff also provides statistical and computational instruction and mentoring to students in the Clinical and Translational Science (CTS) program within the Graduate School of Biomedical Sciences at Tufts University.


BERD staff members collaborate with investigators at Tufts Medical Center, Tufts University, Tufts MC-affiliated institutions (e.g. Lahey Clinic and St. Elizabeth’s Medical Center), as well as with investigators from non-affiliated universities and hospitals, government agencies, non-profit organizations and industry. Areas of clinical collaboration include cardiology, critical care medicine, emergency medicine, HIV-AIDS, infectious diseases, nephrology, nursing, nutrition, oncology, ophthalmology, pediatrics,  pharmacy, psychiatry, pulmonary, rheumatology, and transplantation.


Janis L. Breeze, MPH 
Associate Director, Biostatistics, Epidemiology, and Research Design (BERD) Center

Paola Sebastiani, PhD
Director, Biostatistics, Epidemiology, and Research Design (BERD) Center.

Norma Terrin, PhD
Scientific Director, Biostatistics, Epidemiology, and Research Design (BERD) Center 


Tara Fleckner, MPH
Research Project Coordinator

Rachael Huebner, MPH
Clinical Data Manager

Benjamin Koethe

Jason Nelson, MPH

Jessica K. Paulus, ScD
Assistant Professor of Medicine, Tufts University School of Medicine

Lori Lyn Price, MAS
Assistant Professor

Robin Ruthazer, MPH
Senior Statistician

Hocine Tighiouart, MS
Assistant Professor

Mailing Address

Biostatistics, Epidemiology, and Research Design (BERD) Center
The Institute for Clinical Research and Health Policy Studies
Tufts Medical Center
800 Washington Street, Box #63
Boston, MA. 02111

Physical Location
35 Kneeland Street, 9th floor
Boston, MA 02111