Epidemiologist II

TALENT Software Services; Rahway (NJ); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking an Associate Principal Scientist to lead global Clinical Outcome Assessment strategies. In this dynamic role, you will coordinate COA/PRO plans to align with product goals, guide the selection of assessment instruments, and ensure compliance with regulatory requirements. You will be at the forefront of developing and validating methodologies that enhance clinical trials and observational studies. Join a passionate team committed to advancing healthcare through innovative research and make a significant impact on patient-centered outcomes.

Qualifications

• PhD or Master's in relevant field with industry experience in COA.
• Strong knowledge of COA methodologies and regulatory requirements.

Responsibilities

• Coordinate global COA/PRO strategic plans for clinical teams.
• Facilitate the selection and implementation of COA/PRO instruments.
• Produce scientific communications and keep up with COA methodologies.

Skills

Project Management

Communication Skills

Data Analysis

Understanding Regulatory Requirements

Education

PhD in Health Services Research

Master's Degree in Health Services Research

Bachelor's Degree in Health Services Research

Tools

MS Office Suite

Job description

Under the general direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcome 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.

Primary activities include but are not limited to:

• Coordinate global COA/PRO strategic plans in support of Early Development Teams (EDTs), Clinical Trial Teams (CTT) and/or Clinical Sub-teams (CST) to assure alignment with product franchise goals.
• Provide assistance on the selection and/or development of COA/PRO instruments for inclusion in studies.
• Provide guidance on implementing COA/PRO instruments into studies by following *** standard processes.
• Facilitate alignment of the selection of an appropriate endpoint measure to satisfy both regulatory and reimbursement needs.
• Coordinate COA/PRO related sections of evidence packages to be submitted to regulatory and reimbursement agencies.
• Coordinate the development, validation, implementation, and utilization of instruments aimed at measuring COA/PROs in the context of clinical trials and/or observational studies.
• Conduct literature searches to support COA/PRO endpoint strategies.
• Support/Produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.)
• Keep up to date with COA/PRO methodologies and guidelines (including those from regulatory authorities and reimbursement agencies) and communicate findings to cross-functional study teams as needed.

Qualifications:
Education:

• PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or closely related field with 3+ years of relevant industry work experience in the Clinical Outcome Assessment (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 Clinical Outcome Assessment (COA).

Required Experience:

• Familiar with Clinical Outcome Assessment (COA) endpoint strategies, including Patient-Reported Outcomes requirements for regulatory and reimbursement agencies.
• Knowledgeable of methodological approaches and technical aspects (i.e. study design, data analysis and interpretation) of COA/PRO development, validation, electronic migration and interpretation into clinical trial and observational studies.
• Ability to understand and respond to multiple internal and external customers.
• Strong project management and communication skills.
• Experience with COA/PRO-related scientific presentations and publications.

Software: MS office suite
Personality:

• Excellent communications skills.
• Take initiatives to understand the role.
• Curious about what we do.
• Eager to understand more about this role.
• Adapts well within the group.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Other

Industries

IT Services and IT Consulting