Pre-conference Course 1

Quick-thinking, Confident, Communicative, and Collaborative: Fundamentals of Applied Improvisation for (Bio)statisticians and Data Scientists
Speaker: Richard C. Zink, PhD

(Bio)statisticians and data scientists are technically proficient. This is unsurprising, since their education focuses on developing quantitative scientists of the highest order. However, this leaves little opportunity for the development of interpersonal skills which are often just as important for success. Ironically, many of the skills leading to technical success can stifle innovation, limit awareness, and inhibit communication. But all is not lost! Applied improvisation is a novel (and fun) way to pursue and practice interpersonal skills that are un- or under-developed. Applied improvisation is the application of the principles of improvisational theater in non-theatrical settings; it has been used for decades to assist students in developing and expanding quick thinking, confidence, communication, and collaboration.

This half-day professional development course introduces individuals to applied improvisation from the perspective of a fellow quantitative scientist. Through several physical and verbal exercises, participants explore interpersonal skills such as creativity, spontaneity, adaptability, courage, and storytelling. Briefings examine how exercises reinforce various competencies and how they relate to the workplace. No experience is required, just an open mind, an eagerness to participate, and a willingness to take risks in a supportive environment.

Learning objectives
1. Recognize how applied improvisation develops and reinforces interpersonal sills appropriate for the workplace.
2. Summarize the skills various physical and verbal exercises emphasize and how exercises can improve communication, collaboration, and spontaneity.
3. Implement feedback and peer evaluation to improve listening, support others, and communicate more effectively.
4. Critique the effectiveness of individual physical and verbal exercises for personal skill development.

Pre-conference Course 2

Adjusting for Covariates in RCTs: Translating Guidance into Practice
Speakers: Dominic Magirr (Novartis, Basel, Switzerland), Alexander Przybylski (Novartis, United Kingdom)

The FDA’s 2023 guidance document on Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products emphasizes key principles while introducing new techniques. This course aims to enhance participants’ understanding and implementation of these techniques in study protocols and statistical analysis plans. Focus will be placed on defining the target estimand and its impact on estimation procedures, including the calculation of treatment effect estimator variance. Hands-on exercises and case studies will provide practical experience in executing covariate adjustment analyses across different scenarios. The target audience for this course is statisticians involved in the design and analysis of randomized clinical trials with continuous, binary, and time-to-event endpoints. Throughout the agenda, participants will explore the guidance, examine practical implications, gain hands-on experience, and learn how to apply these techniques effectively to their own trials.

Learning objectives:
Participants will be able to identify in which contexts covariate adjustment is useful, and be able to engage in discussions with different stakeholders on the pros and cons of covariate adjustment. Participants will also learn how to specify covariate adjusted analyses in study protocols and statistical analysis plans, as well as how to execute covariate adjusted analyses for continuous, binary and time-to-event endpoints.

Prerequisites:
Participants are required to have some familiarity with clinical trial design, including an awareness of the ICH E9 Addendums on Estimands. Some basic knowledge of R software is also assumed. Participants need to bring their own laptop. Practical sessions will be run in Posit cloud.