Director: Ken Cheung, PhD
The MS in Biostatistics Pharmaceutical Statistics Track provides study design, research, and biostatistics skills to individuals 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
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.
Statistical Computing Using SAS
New Drug Development: A Regulatory Overview
Principles of Epidemiology
Analysis of Categorical Data
Biostatistical Methods I
Introduction to Randomized Clinical Trials
Research Data Coordination: Principles and Practice
Capstone Consulting Seminar
Students also select 2+ courses from the list below. Other advanced courses from the Department of Biostatistics, other Departments in the Mailman School of Public Health, or elsewhere at Columbia may be substituted with approval of the student's academic advisor.
Introduction to Health Economics
Applied Regression I
Design of Medical Experiments
Adaptive Designs for Clinical Trials
Stochastic Approximation and Modern Dose-Finding
Biopharmaceutical Development and Regulation
Below is a sample timeline for MS/PS candidates. Note that course schedules change from year to year, so that class days/times in future years will differ from the sample schedule below; you must check the current course schedule for each year on the course directory page.
|Fall I||Spring I||Fall II||Spring II|
|P8130-Biostatistical Methods I||P6170-New Drug Development: A Regulatory Overview||P8120-Analysis of Categorical Data||P8144-Pharmaceutical Statistics|
|P8104-Probability||P8140-Introduction to Randomized Clinical Trials||P8142-Clinical Methodology||P8185-Capstone Consulting Seminar|
|P6400-Principles of Epidemiology||P6110-Statistical Computing Using SAS||P8180-Research Data Coordination||Completion of practicum requirements|
One term of practical experience is required of all students, providing educational opportunities that are different from and supplementary to the more academic aspects of the program. The practicum may be fulfilled during the school year or over the summer. Arrangements are made on an individual basis in consultation with faculty advisors who must approve both the proposed practicum project prior to its initiation, and the report submitted at the conclusion of the practicum experience. Students will be required to make a poster presentation at the department’s Annual Practicum Poster Symposium which is held in early May.
A formal, culminating experience for the MS degree is required for graduation. The capstone consulting seminar is designed to enable students to demonstrate their ability to integrate their academic studies with the role of biostatistical consultant/collaborator, which will comprise the major portion of their future professional practice.
As part of the seminar, students are required to attend several sessions of the Biostatistics Consulting Service (BCS). The Consultation Service offers advice on data analysis and appropriate methods of data presentation for publications, and provides design recommendations for public health and clinical research, including preparation of grant proposals. Biostatistics faculty and research staff members conduct all consultation sessions with students observing, modeling, and participating in the consultations.
In the capstone seminar, students present their experience and the statistical issues that emerged in their consultations, developing statistical report writing and presentation skills essential to their professional practice in biomedical and public health research projects.
Justine Herrera, MA
Director of Academic Programs
Department of Biostatistics
jh2477 [at] columbia.edu