Graduate Certificate in Modern Biostatistics in Clinical Trials

The national concern regarding the rising costs of health care and the abundance of medical clinical trials being conducted worldwide, underscores the need for biostatisticians trained in the design and analysis of efficient clinical trials. The certificate program in Modern Biostatistics in Clinical Trials is designed for students who want to become familiar with a variety of types of clinical trial designs and data, including traditional, Bayesian, and adaptive designs, as well as FDA regulations, ethics analysis, and reporting for clinical trials.


To be eligible applicants must have:

  1. a bachelor’s degree in statistics, biostatistics, or public health with an appropriate quantitative background or be enrolled in a program for a graduate degree in a public health-related field
  2. completed prerequisite statistical courses
  3. statistical programming experience.

Although open to all current MPH students who meet the prerequisites, this certificate program is best for MPH biostatistics or epidemiology concentrators who have a specific interest in clinical trials.

Application requirements

For application deadlines, requirements, and instructions, please visit the Admissions section for Graduate Certificates in Biostatistics.


  1. Completion of 16 credits of coursework
    1. These courses must include:
      • BS851: Applied Statistics in Clinical Trials I
    2. The remaining courses may be selected from among:
      • BS722: Design and Conduct of Clinical Trials
      • BS810: Meta-Analysis for Public Health & Medical Research
      • BS861: Applied Statistics in Clinical Trials II
      • BS854: Bayesian Methods in Clinical Trials
      • BS856: Adaptive Designs Methods in Clinical Trials
      • BS901: Directed Study in Biostatistics
      • BS902: Directed Research in Biostatistics
  2. No more than 4 credits of Directed Study or Directed Research may count toward the certificate. Continuing student status may not apply towards the certificate.
  3. A grade of B must be obtained in all coursework counting towards the certificate.
  4. At least one presentation on research or literature at the Statistical Clinical Trials Working Group
  5. Complete at least one piece of substantial research in the field of clinical trials leading to a first or second author position on an abstract submitted to a national/international meeting in clinical trials or leading to primary or secondary authorship on a manuscript submitted to a peer reviewed journal. Research for the certificate may be completed as part of a dissertation or an existing collaboration or project in which the student is involved. If the student does not have a research opportunity available to him/her, they will identify one of the Clinical Trials certificate faculty members as a research mentor.

Upon completion of the Modern Biostatistics in Clinical Trials graduate certificate, students will be able to:

  • apply principles of good design, conduct, and monitoring of clinical trials;
  • identify optimal and practically feasible study designs for given hypotheses and calculate the parameters (e.g., sample size, power) corresponding to the design;
  • and analyze clinical trial data; interpret and communicate analysis results in both technical and nontechnical terms through written and oral presentation.

Students currently enrolled in the Boston University MPH or Biostatistics Program (MA or PhD), may count courses towards both their degree and the certificate. However, completion of the certificate may require taking additional credits beyond the degree requirements. Courses from the above list taken at Boston University prior to enrollment in the certificate program can be counted towards the completion of the certificate. However, the certificate cannot be awarded to students or alumni who completed all requirements prior to the initiation of this certificate program.