Clinical Outcomes & Epidemiology

Job Title: Associate Principal Scientist, Clinical Outcomes & Epidemiology

Location: West Point, PA or Rahway, NJ (Hybrid – 3 days onsite per week)

Duration: 2 years

Department: Patient-Centered Endpoints & Strategy (PaCES)

Shift: Monday – Friday, 8 AM – 5 PM EST

Education & Experience Requirements

Candidates must meet one of the following educations and experience criteria:

·        PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a related field, with 3 years of relevant industry experience in Clinical Outcome Assessment (COA).

·        Master’s Degree in the same fields, with 5 years of relevant industry experience in COA.

·        Bachelor’s Degree in the same fields, with 10 years of relevant industry experience in COA.

Required Skills & Experience

·        Expertise in Clinical Outcome Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PROs) for regulatory and reimbursement agencies.

·        Strong knowledge of methodological approaches and technical aspects of COA/PRO development, validation, electronic migration, and interpretation in clinical trials and observational studies.

·        Ability to collaborate with internal and external stakeholders effectively.

·        Project management and communication skills to coordinate and execute endpoint strategies.

·        Experience in scientific presentations and publications related to COA/PRO.

Technical Skills

·        Proficiency in Microsoft Office Suite.

Preferred Attributes

·        Strong communication and interpersonal skills.

·        Proactive and curious about the role and its impact.

·        Team-oriented, adaptable, and eager to learn.

Responsibilities

Under the direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist will:

·        Develop and coordinate global COA/PRO strategies for specific disease areas, ensuring alignment with product franchise goals.

·        Support teams in developing, validating, analyzing, and interpreting COA endpoints for regulatory submissions, reimbursement evidence dossiers, and payer interactions.

·        Work cross-functionally with Clinical Research, Regulatory Affairs, Biostatistics, and Outcomes Research teams to ensure proper execution of COA endpoint strategies.

·        Provide guidance on selecting and implementing COA/PRO instruments in clinical trials, ensuring compliance with company standards and regulatory requirements.

·        Align endpoint measures with both regulatory and reimbursement needs.

·        Conduct literature reviews to support COA/PRO strategies.

·        Develop and contribute to scientific publications, including abstracts, posters, podium presentations, and manuscripts.

·        Stay updated on COA/PRO methodologies and guidelines from regulatory and reimbursement agencies and share insights with study teams.