Associate Principal Scientist

Primary Talent Partners has a Hybrid 2-year contract Associate Principal Scientist (Clinical Outcomes Assessment) opening with a Fortune 100 Pharmaceutical company located at the West Point, PA site. Pay range for this position is between $60 to $70 per hour.

Please note: You will be sitting on a W2 with Primary Talent Partners at an hourly basis without PTO/Benefits - We cannot provide sponsorship or accept C2C, OPT, or 1099 candidates

Overview:

Under the guidance of the Patient-Centered Endpoints & Strategy (PaCES) group lead, the Sr. Clinical Scientist will play a pivotal role in coordinating global Clinical Outcomes Assessment (COA) endpoint strategies, focusing on Patient-Reported Outcomes (PROs) for specific disease areas. This role involves collaborating with cross-functional teams to develop, validate, analyze, and interpret COA endpoints, ensuring alignment with product strategy and regulatory requirements.

Responsibilities:

Coordinate global COA/PRO strategic plans to support Early Development Teams (EDTs), Clinical Trial Teams (CTT), and/or Clinical Sub-teams (CST) in alignment with product franchise goals.

Assist in the selection and/or development of COA/PRO instruments for inclusion in studies.

Provide guidance on implementing COA/PRO instruments into studies, adhering to standard processes.

Facilitate alignment of endpoint measures to meet regulatory and reimbursement needs.

Coordinate COA/PRO related sections of evidence packages for submission to regulatory and reimbursement agencies.

Oversee the development, validation, implementation, and utilization of instruments for measuring COA/PROs in clinical trials and observational studies.

Conduct literature searches to support COA/PRO endpoint strategies.

Support the production of scientific communications such as abstracts, presentations, and manuscripts.

Stay updated with COA/PRO methodologies and guidelines, communicating findings to cross-functional teams as needed.

Qualifications:

Education: PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research, or related field with 3+ years of industry experience OR Master's Degree in relevant field with 5+ years of industry experience OR Bachelor's degree with 10+ years of industry experience in COA.

Familiarity with COA/PRO requirements for regulatory and reimbursement agencies.

Knowledge of COA/PRO development, validation, and interpretation in clinical trials and observational studies.

Strong project management and communication skills.

Experience with COA/PRO-related scientific presentations and publications.

Proficiency in MS Office suite.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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