Research Scientist

Responsibilities:

Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for specific disease areas.

The individual will support teams on the development, validation, analysis, and interpretation of COA endpoints to support regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications. The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies are consistent with and correctly executed to support the product strategy.

A Clinical Outcome Assessment (COA) Instrument is a standardized formal perception-based clinical assessment instrument that quantifies a clinical study participant's health outcome.

Types of COAs: Patient-reported outcome (PRO) measures. Observer-reported outcome (ObsRO) measures.

Clinician-reported outcome (ClinRO) measures.

Performance outcome (PerfO) measures.

PROs provide information on the patient's health condition as directly reported by the patient, without outside interpretation from anyone.

How are patients feeling? Collect health status of patients and how to collect it?

How do we make sure the correct questions are being asked to patients in the clinical trial? Patient reported data.

Existing questionnaires to be included in the studies.

Must have on resumes: COA endpoint strategies, PROs, patient inputs, regulatory interaction, literature review, prepare questionnaires for patients in the trial, review trial protocols and analysis plans.

Education:

PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 3+ years of relevant industry work experience in the COA field OR Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 5+ years of relevant industry work experience in the COA field OR Bachelor's degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 10+years of relevant industry work experience in the COA.