This internship is in Patient-Centered Outcomes Research (PCOR), a core function within Product Development Data Sciences and Analytics that provides strategic leadership and scientific rigor across Development at Roche. PCOR collaborates in cross-functional teams on clinical trials, focusing on patients’ experiences with a disease or condition, e.g., symptoms, impacts on functioning or Health-Related Quality of Life (HRQOL), experience with treatment, preference for outcomes and treatments. HRQoL endpoints are crucial measures in clinical development, increasingly mandated by regulatory bodies like the FDA. The reliability of these measures depends entirely on the psychometric integrity of the Patient-Reported Outcome (PRO) questionnaires used. However, traditional psychometric validation (e.g., assessing cultural bias or measurement stability over time) is slow. This 12-week internship proposes an innovative solution by leveraging Large Language Models (LLMs) to serve as high-throughput synthetic semantic models and synthetic participants. The project’s dual focus is on robustifying Roche’s proprietary instruments and demonstrating a faster, data-driven approach to clinical trial planning. Primary Focus: Assessing Questionnaire Robustness and Developing Guidelines: The core deliverable of this project is the creation of a Proposed Guideline/Protocol for LLM-based psychometric screening. This guideline will be built through practical application on a selected Roche-developed HRQoL questionnaire. Secondary Focus: Power Calculation Pilot: This phase involves validating the LLM's utility as a synthetic participant for clinical trial planning. A pilot study will generate synthetic patient data for a single high-priority HRQoL endpoint (e.g., Physical Functioning) across two trial arms and time points. The LLM-generated data will be analyzed to calculate the two critical inputs required for power calculations. This internship position is located in South San Francisco, on-site. The Opportunity Develop experience in statistical analysis of clinical trial data. Apply LLM to clinical trial data. Learn about the role of data sciences in drug development.
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Job Type
Full-time
Career Level
Intern
Number of Employees
5,001-10,000 employees