01Responsibilities
Scientific Leadership &
Study Design Lead the scientific design of observational studies, defining research questions, study populations, exposure/outcome definitions, and analytical approaches Develop and own protocols, statistical analysis plans, and analysis specifications for RWE projects, ensuring methodological rigor and alignment with internal standards Conduct and document study feasibility assessments, evaluating data source appropriateness and analytical viability Define codelist specifications and variable definitions for data analysts to implement; review completed codelists for clinical and scientific accuracy Provide scientific direction on study amendments and respond to methodological questions from cross-functional partners Project Oversight &
Coordination Serve as the scientific point of contact for assigned RWE projects, coordinating timelines and deliverables with Data Analysts and other team members Track and document project communications, decisions, and risks; proactively escalate issues to team lead Review analytical outputs for scientific accuracy and alignment with SAP specifications; provide clear feedback to Data Analysts Ensure project documentation is complete, audit-ready, and compliant with SOPs and internal requirements Scientific Interpretation &
Communication Interpret analytical results within the clinical and scientific context
Translate findings into actionable insights for medical affairs stakeholders author study reports, manuscripts, and scientific communications
Present findings to internal and external audiences Quality &
Standards Conduct scientific quality review of study outputs, focusing on clinical interpretation, methodological soundness, and alignment with objectives Contribute to the development of department-level scientific standards, templates, and best practices for RWE study design and reporting Support continuous improvement initiatives that enhance the scientific rigor and impact of evidence generation activities Team Development &
Collaboration Mentor junior research analysts on scientific methods, study design principles, and stakeholder engagement Partner effectively with Data Analysts, providing clear scientific direction while respecting their technical expertise in execution Support onboarding of new team members on scientific processes and methodologies Minimum
02Requirements
Education: Bachelors degree in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or equivalent. And 5 years conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry (e.g., clinical research, statistics, epidemiology, pricing). Or Masters degree in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or similar. And 3 years of experience conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry. Or PhD in a field such as epidemiology, biostatistics, statistics, bioinformatics, economics or similar. And 2 years of experience conducting research in the pharma industry, contract research organization, or academic institute; or experience in a closely related discipline within the pharma industry. Track record of operational excellence in field of analytics (Data Management and Statistical applications; programming knowledge in either R, STATA, or WinBUGs is a plus).
Experience with data from electronic medical records, registry databases, and external insurance claims databases for health outcomes research. Additional experience in epidemiology, market research, or clinical research is a plus.
Experience in the application of statistical methods to the analysis of observational data. Expert in applied statistics. Extensive experience in the application of statistical methods for analysis of observational data including propensity scores, sensitivity analyses, etc. is a plus.
Experience in creating, reviewing, and maintaining codelists aligned with ICD-9, ICD-10, NDC, HCPCS, LOINC coding .