Hybrid role - 3 days onsite

Required Experience:

• Familiar with COA/PRO 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

Responsibilities:

Under the general direction of the Patient-Centered group lead, the Associate Principal Scientist has responsibility for coordinating global Clinical Outcomes 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 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.

Education:

PhD in Health Services Research, Statistics, Psychometrics, Outcomes Research,

or closely related field with 3+ years of relevant industry work experience in the 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 COA.