Clinical Application Specialist II

The Clinical Application Specialist II Data Analytics supports the Global Epidemiology function within Clinical Sciences by providing advanced expertise in real-world data and analytical methods. This fully remote role develops and executes data and statistical analysis plans with minimal technical oversight and independently delivers clear, actionable findings to epidemiologists and cross-functional partners. The specialist conducts comprehensive literature reviews, supports the design and evaluation of observational studies, and provides critical epidemiology data to core safety and regulatory documents while using modern analytics tools and real-world data sources.

• Apply general to advanced epidemiology research techniques to address questions related to drug safety using appropriate research methods.
• Identify, access, and utilize relevant public and private epidemiology resources and databases for real-world data analysis.
• Independently develop and manage data and statistical analysis plans for specific epidemiology databases, including preparation of relevant tables, figures, and summaries.
• Perform complex data analyses using real-world data and clearly communicate results, interpretations, and findings to epidemiologists and cross-functional team members.
• Contribute to the design of observational studies, including registries, by providing critical appraisal of observational study protocols and participating in inter-departmental and cross-functional committees as needed.
• Convert sales data into exposure data, both overall and stratified by key factors such as age groups, gender, and indications by leveraging real-world data sources.
• Provide epidemiology data and analytical outputs to core safety and regulatory documents, including but not limited to Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and Briefing Books.
• Perform comprehensive literature reviews on real-world data analytics methodologies and coding algorithms to support robust study design and analysis.
• Offer insights into real-world data analysis tools, epidemiology study concepts, and study protocols and proposals.
• Use and optimize analytical tools such as SAS, SQL, R, and Aetion for data analysis, modeling, and visualization.
• Support clinical applications and user communities by providing user support and training related to analytics and real-world data use in clinical research.
• Collaborate with clinical research and other functional teams to ensure that analytical outputs align with scientific, clinical, and regulatory objectives.

• MPH or MS degree in Epidemiology, Health Services Research, Pharmacy Administration, or a related field.
• Ph.D. in a relevant field is preferred.
• 45 years of epidemiology and/or public health experience with a Masters degree, or 12 years of experience with a Ph.D. degree.
• Experience in the pharmaceutical or related industry is preferred.
• Proficiency with SAS, SQL, R, or related statistical software for data analysis, modeling, and visualization.
• Extensive experience manipulating and analyzing real-world data such as health insurance claims and electronic medical records (EMRs), including strong understanding of their concepts and structures.
• Strong knowledge of real-world data methodologies, including coding algorithms and analytics approaches.
• Familiarity with multiple therapeutic areas and their associated epidemiology.
• Ability to independently design and execute data and statistical analysis plans with minimal technical oversight.
• Ability to clearly present complex analytical findings to epidemiologists and cross-functional stakeholders in a concise and understandable manner.
• Experience supporting clinical research activities with data analytics and clinical application support.

• Experience with Aetion or similar real-world data analysis platforms for observational research and causal inference.
• Background in health services research, pharmacy administration, or related disciplines that support outcomes and real-world evidence generation.
• Exposure to or experience with core safety and regulatory documentation such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and regulatory Briefing Books.
• Experience contributing to the design and critical review of observational studies, including registries.
• Strong literature review skills, particularly in real-world…