Biostatistics

Co-directors: Roger Vaughan, DrPH, MS, and Ken Cheung, PhD

The MS in Biostatistics Pharmaceutical Statistics Track provides study design, research, and biostatistics skills to individuals who are currently working in the pharmaceutical research industry and those seeking to begin a career in the industry. By the end of the experience, graduates of the program will be able to:

• Explain the FDA process of drug and device approval
• Classify clinical trials according to the research phase
• Choose a design appropriate to the research question, disease, research phase, and therapy under consideration
• Design an analytic plan appropriate for the selected experimental data
• Prepare the information necessary, and in proper form, for FDA’s drug and device approvals

Requirements

Those applying to the MS in Pharmaceutical Statistics should have a strong background in mathematics (at least two semesters of calculus) and experience or interest in working in the pharmaceutical industry. 

Students must fulfill at least 35 credits of coursework and complete the Clinical Trials Network rotation. Students will be required to spend one semester in the Biostatistics Center for Clinical Trials Management.

This degree is designed for working professionals. Therefore, we strongly suggest starting in the summer before the first fall semester in order to complete the program in one year.

Course Work

Required Courses (29 Credits):

• P6104- Introduction to Biostatistics
• P6400- Introduction to Epidemiology
• P6110- Statistical Computing with SAS
• P8180- Research Data Coordination: Principles and Practice
• P8120- Analysis of Categorical Data
• P8140- Randomized Clinical Trials I
• P8142- Randomized Clinical Trials II
• P8144- Randomized Clinical Trials III
• P8146- Drug Development from a Pharmaceutical Perspective
• P8148- FDA Regulatory Overview
• P8143- Biostatistics in Industry 

Elective Courses (2+ Classes, 6+ Credits):

• P8100- Applied Regression I
• P8104- Probability
• P8109- Statistical Inference
• P8116- Design of Medical Experiments
• P8117- Nonparametric Statistics
• P8134- Stochastic Approximation and Modern Dose-Finding
• P8133- Sequential Experimentation
• G4010- Responsible Conduct of Research
• G4200- Biopharmaceutical Development & Regulation