Epidemiologist

Primary Responsibilities/Accountabilities:

• 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 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.
  

Qualifications:

• 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.
• 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
  

Preferred:

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