ASA Connect

2021 UConn Statistics Virtual Biopharmaceutical Summer Academy

This year we have re-designed the academy as a 1-credit course, BIST 5092. This two-week virtual, 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 based on R and SAS. 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 visit https://events.stat.uconn.edu/BI-UConn/summercourse.html for more details.

 

In addition to the instruction time between 8/16-8/26, the course also includes your registration in a two-day conference (Aug 27-28), Statistics in Pharmaceuticals (SIP2021). The SIP2021 conference is sponsored by Amgen, Biogen, Boehringer-Ingelheim, Bristol Myers Squibb, Pfizer, 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 SIP2021 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.  Your course projects will be presented during the 2-day conference on August 27-28. 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. Click here to get more information and apply.

 

Please register for this course through Student Admin.  Non-BIST students' email tracy.burke@uconn.edu for permission number to enroll.   

 

Tentative BIST 5092 syllabus

The actual time and content may change in the final version.

 

WEEK 1

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:-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.

 

WEEK 2

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 A review of FDA and EMA guidance about multiplicity adjustment
Wednesday 8/25/2021	9:30-11:30	Adaptive Design: Methodology in COVID-19 Vaccine case study Seamless design
Thursday 8/26/2021	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.
Friday – Saturday 8/27-28/2021	Full day	Attending Statistics in Pharmaceuticals Conference (SIP 2021)

 

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Dooti Roy
Senior Principal Therapeutic Area Methodology Statistician
Boehringer Ingelheim Pharmaceuticals, Inc.
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