This year we have re-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..
Course Instructors: Qiqi Deng and Dooti Roy
Tentative BIST 5092 syllabus
The actual time and content may change in the final version.
Days | Time | Topic |
Monday 8/16/2021 |
9:00 – 10:00 | Case Study – clinical development of an anti-inflammatory drug |
10:00 - 10:15 | Break | |
10:15 – 12:00 | Overview of phase I/II/III clinical trial design and methodology | |
Tuesday 8/17/2021 |
9:00 - 9:45 | Case study (Part 1): Background of the project, Clinical Development Plan |
9:45 - 10:45 | Case study (Part 2): Introduction to Phase 2 protocol, and Statistical Considerations | |
10:45 - 11:00 | Break | |
11:00 - 12:00 | Case study (Part 3): Introduction to Phase 3 protocol, and Statistical Considerations | |
Wednesday 8/18/2021 |
9:00 - 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 |
9:45 - 10:00: | Break | |
10:00 - 12:00 | Data Standard (CDISC/SDTM/ADaM) and statistical programming of clinical trials | |
Thursday 8/19/2021 |
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 |
Friday 8/20/2021 |
9:30 - 11:30 |
Estimand in clinical trials Examples of intercurrent events and missing data across different Therapeutic areas. |
Days | Time | Topic |
Monday 8/23/2021 |
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 | 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 OR Optimizing Your Use of LinkedIn (2 concurrent sessions |
|
Tuesday 8/24/2021 |
9:30 - 11:30 |
Multiplicity adjustment
|
Wednesday 8/25/2021 |
9:30 - 11:30 |
Adaptive Design:
|
Thursday 8/26/2021 |
9:30 - 11:30 |
Leverage historical data and data synthesis.
|
8/27-28, 2021 |
Attending Statistics in Pharmaceuticals Conference |