01Responsibilities
Scientific Leadership & Study DesignLead the scientific design of observational studies, defining research questions, study populations, exposure/outcome definitions, and analytical approachesDevelop and own protocols, statistical analysis plans, and analysis specifications for RWE projects, ensuring methodological rigor and alignment with internal standardsConduct and document study feasibility assessments, evaluating data source appropriateness and analytical viabilityDefine codelist specifications and variable definitions for data analysts to implement; review completed codelists for clinical and scientific accuracyProvide scientific direction on study amendments and respond to methodological questions from cross-functional partnersProject Oversight & CoordinationServe as the scientific point of contact for assigned RWE projects, coordinating timelines and deliverables with Data Analysts and other team membersTrack and document project communications, decisions, and risks; proactively escalate issues to team leadReview analytical outputs for scientific accuracy and alignment with SAP specifications; provide clear feedback to Data AnalystsEnsure project documentation is complete, audit-ready, and compliant with SOPs and internal requirements Scientific Interpretation & CommunicationInterpret analytical results within the clinical and scientific context; Translate findings into actionable insights for medical affairs stakeholdersauthor study reports, manuscripts, and scientific communications; Present findings to internal and external audiences Quality & StandardsConduct scientific quality review of study outputs, focusing on clinical interpretation, methodological soundness, and alignment with objectivesContribute to the development of department-level scientific standards, templates, and best practices for RWE study design and reportingSupport continuous improvement initiatives that enhance the scientific rigor and impact of evidence generation activitiesTeam Development & CollaborationMentor junior research analysts on scientific methods, study design principles, and stakeholder engagementPartner effectively with Data Analysts, providing clear scientific direction while respecting their technical expertise in executionSupport onboarding of new team members on scientific processes and methodologiesMinimum
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). OrMasters 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. OrPhD 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 conventions for healthcare and real-world data projectsUnderstanding of organizational processes, including experience working The Senior
