This year we have designed the academy as a 1-credit course, BIST 5092. This two-week summer academy will be an immersive, collaborative, dynamic and academic experience for students who are planning to pursue a career as a statistician/programmer in pharmaceuticals and health analytics. The course will teach the basics in pharmaceutical statistics using a project-based learning approach. The content of the course is heavily enriched by real drug examples across different therapeutic area. Students will learn by actively engaging in real-world project for drug development. We hope to bring many of the tools, the newer designs and methods which are used in practice but are rarely covered in school, directly to the students who can benefit from learning them and finding their passion in such a role. It will also cover the use of the software in design and analysis of clinical trials. This course is specifically designed for our current BIST MS students and is also open to STAT MS, PhD and UG students, including non-UConn students (non-BIST students), please see course registration instruction below for more details..


  • Attend the SIP2022 conference
  • Learn about innovative statistical designs for clinical trials
  • Work on mock clinical trials
  • Learn about different phases of drug development
  • Interact with professionals
  • Learn interview tricks and resume writing

Course Registration Instruction

In addition to the instruction time between 7/25-8/5 and the project presentation on 8/19, the course also includes your registration for a two-day conference (Aug 22-23), Statistics in Pharmaceuticals (SIP2022). The SIP2022 conference is sponsored by Amgen, Beigene, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Merck, Moderna, Pfizer, Statistics & Data Corporation (SDC), Servier, Takeda and Vertex. The sponsor companies, together with UConn Department of Statistics and UConn Center for Career Development, organize and provide the programs for the 2-day conference SIP2022 with scholarship opportunities. See the last two days in agenda below for more details.

At the end of the summer program, you will receive an official UConn transcript for taking BIST 5092. Selected course projects will be presented during the 2-day conference on August 22-23. We expect that you will benefit from the academy and you can add this experience to your resume.

Scholarships are available to qualifying candidates based on availability of the fund.

UConn students should register for BIST 5092 through Student Admin. Non-BIST students' email tracy.burke@uconn.edu for permission number to enroll. Registration opens Feb 14, 2022.

Non-UConn students need to register through the Registrar's office here, https://nondegree.uconn.edu/. The Registrar will email you with instructions on how to access the system and register for classes.

Course Plan

The course will teach the basics in pharmaceutical statistics using a project-based Learning approach. The content of the course is heavily enriched by real drug examples across different therapeutic area. And the students will learn by actively engaging in real-world project for drug development. It will also cover the use of the software in design and analysis of clinical trials.

Students can choose to be fully remote during the course. However, as the instructors will be on campus on July 25, 2022, we encourage students to be there in person as well, if it is feasible and take advantage of the planned afternoon Lunch and Meet.


30% attendance. 10% Homework 1, 10% Homework 2, 10% Homework 3: Homework is due on August 5th. Office hours will be provided as indicated below. 40% project slides and presentation. As indicated in the course description, we will take a project based learning approach. The project we will work on is a real drug. Background materials and data are available in the course content area. The background material includes the phase II and III protocols and related publications for Brodalumab-a drug to treat Psoriasis and other autoimmune disease. In addition, it includes the full package for the FDA advisory committee meeting, one summary from sponsor and one summary from FDA. The data are simulated pseudo data to mimic the summary statistics in the publication of results. It would be beneficial to read the full package of background materials to understand the big picture of drug development process, especially the clinical stage.

You are encouraged to form teams by yourselves to work on the course project. You may create a post in Discussion Board to recruit members. If you successfully form a team, please inform us at qiqi.deng@uconn.edu and Dooti.roy@uconn.edu by 5:00PM EST on July 30. If we don't hear from you before that, you will be assigned to one of the teams and the teams will be announced by August 1. You will have one more chance to switch teams by sending emails to me before 5:00PM EST on August 2. After that, the teams will start to work on the projects. We encourage the team members to set up calls as needed among themselves to discuss the project. If you have any questions, feel free to reach out to us by email or come to our office hours.

Included in your course is the access to Statistics in Pharmaceuticals (SIP) conference August 22-23. We will provide a code to waive your registration fee. It can be on-site or virtual attendance. Although it is not required, it is encouraged that you may submit your poster for SIP conference. The instruction for submission in at https://events.stat.uconn.edu/SIP2022/#poster. The submission deadline is August 19.

Once completed, please send your presentation to us. On August 19, we will have presentations for the course project. Each team will have up to 30 minutes to present. Details slot and order will be provided later based on number of teams formed. Dooti and Qiqi will grade your project work based on your presentation.

Download the course plan and assessment criteria.


Days Time Topic Presenter Homework Office hour
(Instructors on campus)
9:00-10:30 Overview of phase I/II/III clinical trial
Development process
Qiqi Deng
Dooti Roy
(Room: AUST 344 for students on site)
Information relevant for the project (case study)
10:30-10:45 Break
10:45-11:30 Case study (Part 1): Background of the project, Clinical Development Plan
12:00-2:00 Lunch and Meet
9:30-10:25 Case study (Part 2): Introduction to Phase 2 protocol, and Statistical Considerations Dooti Roy
10:25-10:35 Break
10:35-11:30 Case study (Part 3): Introduction to Phase 3 protocol, and Statistical Considerations
8:30-9:45 Role of Statisticians in a clinical trial conduct
Trial statistical analysis plan (TSAP)
Trial oversight meetings during trial conduct
Database Lock and Clinical Study Report
Dooti Roy
9:45-10:00 Break
10:00-12:00 Data Standard (CDISC/SDTM/ADaM) and statistical programming of clinical trials Hongli Lu
9:30-11:30 Basics for sample size calculation in clinical trials: methodology, examples and implementation using software
(1) Normally distributed endpoint
(2) Binary endpoint
(3) Continuous endpoint
Qiqi Deng HW1
9:30-11:30 Estimand in clinical trials
Examples of intercurrent events and missing data across different Therapeutic areas.
Qiqi Deng HW2 2:00-3:00


Days Time Topic Presenter Homework Office hour
CCD Career Development Day
This is a special activity organized by UConn CCD. It is integrated into the short course agenda for easy access of the information.
10:00-10:30 Introductions and Opening Activity
10:30-11:30 Finding Jobs and Internships
Understanding Job Postings and Applicant Tracking Systems
11:30-12:30 Lunch
12:30-2:00 Resume/CV Presentation and Lab
2:00-3:00 Building a LinkedIn Profile/Optimizing Your Use of LinkedIn
9:30-11:30 Multiplicity adjustment
  • A review of FDA and EMA guidance about multiplicity adjustment
Dooti Roy HW3 2:00-3:00
9:30-11:30 Adaptive Design Qiqi Deng
9:30-11:30 Leverage historical data and data synthesis.
  • Borrowing historical information
  • Borrowing adult trial data for pediatric development
  • Synthesis of data from different resources
Dooti Roy
Office hour only for project related questions. Qiqi Deng
Dooti Roy
10:00-12:30 Project presentation Qiqi Deng, Dooti Roy and all students



8/22-23, 2022

Attending Statistics in Pharmaceuticals Conference