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Senior Manager, Real-World Evidence for Vaccines
2 months ago
POSITION OVERVIEW
The Global Scientific Affairs team focused on COVID-19 and influenza is at the forefront of generating substantial evidence for vaccines, therapeutics, and diagnostics. Within this team, a specialized group of Real-World Evidence (RWE) Scientists, reporting to the Team Lead for COVID & Flu Databases, is responsible for developing and executing evidence generation strategies utilizing internal databases to support assets related to COVID and flu vaccines, antiviral treatments, and diagnostic tools. The Senior Manager in this domain will provide timely feasibility evaluations, rapid real-world insights (RWI), and concise summary reports by aligning with stakeholder objectives and timelines. This role involves contributing to and occasionally leading the creation of RWE protocols in collaboration with cross-functional asset teams and Biostatistics to enhance value generation for all assets.
The Senior Manager will act as a subject matter expert on data sources, offering guidance on the most suitable types of data, datasets, innovative methodologies, and algorithms tailored to specific challenges. They will coordinate RWE project execution with relevant internal and partner analytic resources and tools, ensuring the establishment of consistent business rules, versioning protocols as care pathways evolve, and adherence to standards and procedures.
This position is pivotal in delivering in-house RWE projects and supporting the strategic development of vaccines and antiviral initiatives to adapt to the evolving landscape of real-world evidence.
KEY RESPONSIBILITIES
Direct RWI for feasibility evaluations, making go/no-go decisions, and co-designing dashboards to inform hypothesis generation across cross-functional teams, delivering timely and detailed insights. Collaborate with team members to foster robust internal and external partnerships, serving as a subject matter expert by providing consultations on all facets of RWD studies and analyses, including feasibility evaluations, objectives, study design, data source identification, protocol development, statistical analyses, and table shells. Enhance RWD and analytics capabilities, leading the application of advanced analytics methodologies, analysis tools, and visualization platforms to generate innovative insights and actionable strategies. Oversee the execution of rapid RWD-based queries and studies, effectively communicating findings and results to internal stakeholders through tables, visualizations, concise reports, and presentations. Contribute to and/or lead external publications, including conference abstracts, posters, and manuscripts. Establish standards and processes to manage the quality, consistency, usability, security, and availability of data throughout its lifecycle, staying informed on best practices in RWD/E. Coordinate and drive collaboration among internal cross-functional teams, Biostatistics, and other colleagues to produce high-quality RWE from rigorously designed protocols. Engage with various stakeholders, including pipeline/asset teams, RWE Operations Leads, Biostatistics, and Digital RWD, to collaboratively develop high-quality methods, innovative approaches, protocols, and designs. Contribute to asset medical strategy and evidence generation planning. Identify opportunities to automate processes and create efficiencies, harmonizing rules with other analysis teams, and ensuring all deliverables are integrated into the Digital RWD knowledge and insights management system. Evaluate vendor due diligence for potential partnerships or new data/technology sources as directed. Document all requests, track project progress, create and measure quarterly ROI metrics, and ensure alignment with business objectives.BASIC QUALIFICATIONS
The ideal candidate will possess a Master's degree with over 5 years of experience or a PhD with at least 2 years in RWE analytics or consulting, Nursing or Biomedical Informatics, Public Health, HEOR, Epidemiology, or other related fields with a significant quantitative and computational focus.
Proven track record in scientific analysis of real-world data for various purposes. Familiarity with Electronic Health Records, medical and pharmacy claims, patient registries, and other real-world data sources. Advanced understanding of pharmacoepidemiologic methods and study design. Strong communication skills, both verbal and written, with the ability to present complex information clearly to diverse audiences. Detail-oriented and organized, with the ability to work under pressure and adapt quickly in a dynamic environment. Experience in protocol development and execution for non-interventional studies using various analytical techniques. Significant hands-on experience analyzing diverse types of real-world data, including EHR, claims, registry data, and laboratory results. Proficiency in query and analytic languages and technologies, such as SQL, R, and SAS.PREFERRED QUALIFICATIONS
3+ years of experience in real-world data analytics within healthcare, clinical research, or life sciences. Knowledge of vaccine development, infectious diseases, and immunology is highly desirable. Understanding of global regulatory guidance for RWE submission is preferred. Experience with clinical registries and patient-generated health data is a plus. Skills in managing and analyzing large databases, including data visualization and exploratory data analysis.ADDITIONAL REQUIREMENTS
Ability to travel periodically as needed.