Pharmaceutical Statistics

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

Required Courses

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. 

Course #

Course Name

Points

P6110 

Statistical Computing Using SAS

3

P6170

New Drug Development: A Regulatory Overview

3

P6400

Principles of Epidemiology

3

P8120

Analysis of Categorical Data

3

P8130

Biostatistical Methods I

3

P8140

Introduction to Randomized Clinical Trials

3

P8142

Clinical Methodology

3

P8144

Pharmaceutical Statistics

3

P8180

Research Data Coordination: Principles and Practice

3

P8185

Capstone Consulting Seminar

1

 

Electives

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.

Course #

Course Name

Points

P6503

Introduction to Health Economics

3

P8100

Applied Regression I

3

P8104

Probability

3

P8109

Statistical Inference

3

P8116

Design of Medical Experiments

3

P8133

Adaptive Designs for Clinical Trials

3

P8134

Stochastic Approximation and Modern Dose-Finding

3

P8401

Pharmacoepidemiology

3

GU4200

Biopharmaceutical Development and Regulation

3

 

Sample Timeline

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 ISpring IFall IISpring II
P8130-Biostatistical Methods IP6170-New Drug Development: A Regulatory OverviewP8120-Analysis of Categorical DataP8144-Pharmaceutical Statistics
P8104-ProbabilityP8140-Introduction to Randomized Clinical TrialsP8142-Clinical MethodologyP8185-Capstone Consulting Seminar
P6400-Principles of EpidemiologyP6110-Statistical Computing Using SASP8180-Research Data CoordinationCompletion of practicum requirements
 ElectiveElective 

 

Practictum Requirement

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.

Capstone Experience

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.

Contact

Justine Herrera, MA
Director of Academic Programs
Department of Biostatistics
Columbia University
jh2477 [at] columbia.edu
(212) 342-3417

More information on Admission Requirements.