Associate Principal Scientist (Epidemiology)

Our client, a trailblazing global pharmaceutical powerhouse, renowned for their expertise in developing and manufacturing a wide array of world-class pharmaceutical drugs, life-saving vaccines, and innovative animal-health products, is in search of an Associate Principal Scientist to join their dynamic team.

Type: Contract

Location: North Wales, PA (Hybrid)

Pay: $58.67 - $71.43/hr

Responsibilities

• 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
• 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 ( 3 yrs), MS ( 5 yrs), or BS ( 10 yrs) in Health Services Research, Statistics, Psychometrics, Outcomes Research (or closely related field) with relevant industry work experience in the COA field
• Familiar with COA/PRO requirements for regulatory and reimbursement agencie
• 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 skill
• Experience with COA/PRO-related scientific presentations and publications.
  
  

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!