What are the responsibilities and job description for the Epidemiologist position at Astrix Technology?
Epidemiologist
Clinical
Lansdale, PA, US
Pay Rate Low : 55 | Pay Rate High : 58
- Added - 14 / 02 / 2025
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Our respected client, a leading global pharmaceutical company known for developing life-saving drugs, vaccines, and innovative animal-health products, is looking for a talented Epidemiologist II / III to join their team.
Location : Lansdale, PA
Term : 2 Year Contract Assignment
Pay : 55-58 / hr. depending on education & experience
Job Summary :
Under the direction of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Associate Principal Scientist will coordinate global Clinical Outcome Assessment (COA) strategies, including Patient-Reported Outcomes (PROs) for specific diseases.
This role involves supporting teams in developing, validating, analyzing, and interpreting COA endpoints to assist with regulatory submissions, reimbursement dossiers, payer interactions, and publications. The Associate Principal Scientist will collaborate with teams from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA strategies align with and support the overall product strategy.
Responsibilities :
Coordinate global COA / PRO strategies to align with Early Development Teams (EDTs), Clinical Trial Teams (CTT), and Clinical Sub-teams (CST) to meet product goals.
Assist with selecting and developing COA / PRO instruments for studies.
Guide the implementation of COA / PRO instruments in studies, following company standard processes.
Ensure the selected endpoint measures meet both regulatory and reimbursement requirements.
Coordinate COA / PRO sections of evidence packages for submission to regulatory and reimbursement agencies.
Oversee the development, validation, and use of COA / PRO instruments in clinical trials and observational studies.
Conduct literature reviews to support COA / PRO strategies.
Support or create scientific communications like abstracts, posters, podium presentations, and manuscripts.
Stay up to date with COA / PRO methodologies and guidelines from regulatory and reimbursement agencies, sharing updates with study teams as needed.
Qualifications :
PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a related field with 3 years of relevant experience in the Clinical Outcome Assessment (COA) field,
Master’s Degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a related field with 5 years of relevant experience in the COA field,
Bachelor’s degree in Health Services Research, Statistics, Psychometrics, Outcomes Research, or a related field with 10 years of relevant experience in the COA field.
Knowledgeable about Clinical Outcome Assessment (COA) endpoint strategies, including Patient-Reported Outcomes (PRO) requirements for regulatory and reimbursement agencies.
Experienced in the methods and technical aspects of COA / PRO development, validation, electronic migration, and interpretation in clinical trials and observational studies.
Ability to understand and address the needs of both internal and external stakeholders.
Strong project management and communication skills.
Experience with COA / PRO-related scientific presentations and publications.
LI-DNP
INDBH
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
