Epidemiologist III

Associate Principal Scientist – Patient-Centered Endpoints & Strategy (PaCES)
Department: Patient-Centered Endpoints & Strategy (PaCES)
Work Location: West Point, Rahway (possibly)
Hybrid Role: 3 days onsite (Monday–Thursday)

Qualifications
Education:
PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a closely related field with 3+ years of relevant industry experience in Clinical Outcome Assessment (COA)
OR
Master’s Degree in the same fields with 5+ years of relevant industry experience in COA
OR
Bachelor’s Degree in the same fields with 10+ years of relevant industry experience in COA
Required Experience:
Strong familiarity with Clinical Outcome Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) requirements for regulatory and reimbursement agencies.
In-depth knowledge of methodological approaches and technical aspects (study design, data analysis, interpretation) for COA/PRO development, validation, electronic migration, and implementation in clinical trials and observational studies.
Ability to effectively communicate and respond to multiple internal and external stakeholders.
Strong project management and communication skills.
Experience with COA/PRO-related scientific presentations and publications.

Software Skills:
Proficiency in MS Office Suite.

Personality Traits:
Excellent communication skills.
Proactive and takes initiative in understanding the role.
Curious and eager to learn about COA/PRO methodologies.
Adaptable and works well within a collaborative team environment.

Additional Details:
Preference for candidates with relevant industry experience in COA/PRO.
Resume Requirements:Explain employment gaps and provide complete work history with dates.
Include all publications (if none, mention it on the resume).
Do not include references’ names or contact details.

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

This role supports the development, validation, analysis, and interpretation of COA endpoints to aid in regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.

The Associate Principal Scientist will collaborate with PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint strategies align with product strategy and are correctly implemented.

Primary Responsibilities:
Coordinate global COA/PRO strategic plans to support Early Development Teams (EDTs), Clinical Trial Teams (CTTs), and Clinical Sub-teams (CSTs) to align with product franchise goals.
Assist in the selection and/or development of COA/PRO instruments for clinical studies.
Provide guidance on COA/PRO implementation following company standard processes.
Align endpoint measures to meet both regulatory and reimbursement requirements.
Oversee COA/PRO-related sections in evidence packages submitted to regulatory and reimbursement agencies.
Develop, validate, implement, and utilize COA/PRO measurement instruments for clinical trials and observational studies.
Conduct literature reviews to support COA/PRO endpoint strategies.
Contribute to scientific communications, including:Abstracts
Poster presentations
Podium presentations
Manuscripts
Stay updated on COA/PRO methodologies and guidelines (from regulatory authorities and reimbursement agencies) and communicate key findings to cross-functional study teams.

This position is ideal for candidates passionate about patient-centered outcomes, with strong scientific expertise and cross-functional collaboration skills in a pharmaceutical research setting.