Associate Scientist - Patient-Centered Endpoints & Strategy (PaCES)

The Scientist is responsible for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, with a specific focus on Patient-Reported Outcomes (PROs). Working under the PaCES lead, you will support the development, validation, and interpretation of COA endpoints to drive overall product development and strategy across specific disease areas.

Primary Responsibilities

• Strategy & Collaboration: Work closely with Clinical Research, Regulatory Affairs, Biostatistics, and Operations to ensure COA strategies are consistently executed and aligned with product goals.
• Instrument Development: Provide technical assistance in the selection and/or development of COA/PRO instruments for clinical studies.
• Study Implementation: Guide the implementation of COA/PRO instruments following standard Merck processes.
• Clinical Trial Support: Represent the PaCES lead at Clinical Trial Team (CTT) meetings to ensure alignment on endpoint selection.
• Regulatory Evidence: Assist in coordinating COA/PRO-related sections of evidence packages for submission to regulatory agencies.
• Analysis & Interpretation: Support the development, validation, and utilization of instruments designed to measure patient-centered outcomes in clinical settings.

Candidate Requirements

• Education & Experience
• Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a closely related field with 3+ years of relevant pharmaceutical industry experience.
• OR Bachelor’s Degree in the same fields with 5+ years of relevant pharmaceutical industry experience.

Required Skills & Experience

• Regulatory Knowledge: Familiarity with COA/PRO requirements for regulatory and reimbursement agencies.
• Technical Expertise: Deep understanding of the methodological approaches to COA/PRO development, validation, and electronic migration.
• Communication: Excellent interpersonal and communication skills, with the ability to manage multiple internal and external customers.
• Project Management: Strong project management skills and experience with scientific presentations and publications.
• Analytical Skills: Proven ability in study design, data analysis, and the interpretation of clinical trial and observational study data.