Epidemiologist II

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:
Familiarity with Clinical Outcome Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) requirements for regulatory and reimbursement agencies.
Strong 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 collaborate with 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 in understanding the role.
Curious and eager to learn more about COA/PRO.
Adaptable and works well within a team.

Additional Details:
Work Location: West Point, Rahway (possibly).
Hybrid Role: 3 days onsite (Monday–Thursday).
Preference for candidates with 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.

The individual will support teams in developing, validating, analyzing, and interpreting COA endpoints to aid in regulatory submissions, reimbursement evidence dossiers, payer interactions, and publications.

The role requires close collaboration 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 in support of Early Development Teams (EDTs), Clinical Trial Teams (CTTs), and Clinical Sub-teams (CSTs) to align with product franchise goals.
Provide guidance on the selection and/or development of COA/PRO instruments for clinical studies.
Assist in implementing COA/PRO instruments by following company standards.
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 role is ideal for candidates who are passionate about patient-centered outcomes, have strong scientific expertise, and excel in cross-functional collaboration within a pharmaceutical research setting.