Our client, one of the largest pharmaceutical companies in USA is looking for Epidemiologist II either at Rahway, NJ OR West Point, PA **Actual Title:** Associate Principal Scientist **Department-** Patient-Centered Endpoints & Strategy (PaCES) **Work Location:** West Point, Rahway (possibly) + Hybrid (3 days onsite between Monday-THRU) **Note:** + **Would be great to have more candidates with industry experience in this specific area.** + **Please provide gap explanation and complete work history with dates on the resumes submitted in the system.** + **Please add complete publications on the resume. If someone doesn't have publication, please mention it on the resume. Do not add references name and contact details on resume.** **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. **Responsibilities:** + 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 our client's 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. If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you! **About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells** _ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. 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