Manager, CORE

Manage and provide technical expertise for Phase IV real-world evidence research across the influenza vaccine portfolio, including the development, coordination, and execution of studies focused on influenza epidemiology, vaccine effectiveness, vaccine safety, burden of disease, vaccine use, and vaccine impact. Serve as project manager and technical project analyst for assigned internal- and external-facing studies; make scientific, methodological, and operational recommendations; contribute to evidence-generation strategy, regulatory and medical responses, and internal decision-making; and elevate matters with broader portfolio, strategic, or material resource implications. Develop and review study concepts, protocols, statistical analysis plans, study reports, and internal evidence summaries. Manage vendors, contract research organizations (CROs), database partners, academic collaborators, and investigators; prioritize competing deliverables; develop contingency plans; and address scientific, operational, methodological, timeline, data, and resource risks to ensure scientifically rigorous, high-quality work within timeline and budget expectations. Conduct systematic literature reviews, targeted literature searches, qualitative evidence summaries, and meta-analyses to identify evidence gaps and support evidence-generation plans. Review, interpret, and, where appropriate, conduct statistical analyses of real-world and meta-analytic data in accordance with approved research protocols. Coordinate scientific dissemination through abstracts, congress presentations, manuscripts, and scientific exchange materials, including drafting and journal submission, coordination of author input, responses to reviewers, data interpretation, presentation development, and scientific review. Maintain knowledge of relevant literature, real-world evidence trends, epidemiologic methods, reporting standards, leading authorities, academic institutions, government entities, and emerging methodological approaches, and identify opportunities to improve research processes, methods, and evidence-generation approaches. Participate in CORE, Medical Affairs, and cross-functional project teams and collaborate effectively with internal stakeholders, external experts, professional associations, vendors, and research partners. Ensure that studies and other company activities comply with applicable epidemiologic reporting and quality standards, including STROBE guidance, ClinicalTrials.gov registration requirements, Institutional Review Board requirements, applicable regulations, and company policies and procedures. Responsibilities Manage and provide technical expertise for Phase IV real-world evidence research across the influenza vaccine portfolio, including the development, coordination, and execution of studies focused on influenza epidemiology, vaccine effectiveness, vaccine safety, burden of disease, vaccine use, and vaccine impact. Serve as project manager and technical project analyst for assigned internal- and external-facing studies; make scientific, methodological, and operational recommendations; contribute to evidence-generation strategy, regulatory and medical responses, and internal decision-making; and elevate matters with broader portfolio, strategic, or material resource implications. Develop and review study concepts, protocols, statistical analysis plans, study reports, and internal evidence summaries. Manage vendors, contract research organizations (CROs), database partners, academic collaborators, and investigators; prioritize competing deliverables; develop contingency plans; and address scientific, operational, methodological, timeline, data, and resource risks to ensure scientifically rigorous, high-quality work within timeline and budget expectations. Conduct systematic literature reviews, targeted literature searches, qualitative evidence summaries, and meta-analyses to identify evidence gaps and support evidence-generation plans. Review, interpret, and, where appropriate, conduct statistical analyses of real-world and meta-analytic data in accordance with approved research protocols. Coordinate scientific dissemination through abstracts, congress presentations, manuscripts, and scientific exchange materials, including drafting and journal submission, coordination of author input, responses to reviewers, data interpretation, presentation development, and scientific review. Maintain knowledge of relevant literature, real-world evidence trends, epidemiologic methods, reporting standards, leading authorities, academic institutions, government entities, and emerging methodological approaches, and identify opportunities to improve research processes, methods, and evidence-generation approaches. Participate in CORE, Medical Affairs, and cross-functional project teams and collaborate effectively with internal stakeholders, external experts, professional associations, vendors, and research partners. Ensure that studies and other company activities comply with applicable epidemiologic reporting and quality standards, including STROBE guidance, ClinicalTrials.gov registration requirements, Institutional Review Board requirements, applicable regulations, and company policies and procedures. Qualifications Graduate degree (Master’s or PhD) in public health, epidemiology, biostatistics, pharmacoepidemiology, health outcomes research, or a related scientific discipline; equivalent relevant experience may be considered. Minimum of three years of experience in observational research, real-world evidence generation, epidemiology, health outcomes research, or statistical programming using clinical, claims, registry, or electronic health record data. Strong understanding of Phase IV outcomes research, observational study design, real-world evidence generation, and epidemiologic methods, including comparative effectiveness research, causal inference, confounding control, and vaccine effectiveness methods. Experience using claims databases, electronic health records, registries, published literature, and other real-world data sources, and conducting systematic literature reviews and meta-analyses. Experience programming and reviewing statistical analyses using SAS, SQL, R, Stata, or similar software; R programming experience is preferred. Excellent oral and written communication skills, with the ability to translate complex scientific, epidemiologic, and statistical concepts into clear reports, presentations, publications, and internal evidence summaries. Demonstrated project-management expertise, including the ability to independently manage multiple priorities, ambiguity, timelines, budgets, and quality expectations while exercising sound judgment. Ability to establish productive working relationships, collaborate effectively, and build consensus with colleagues, managers, cross-functional teams, vendors, collaborators, and external experts in a global, highly matrixed environment. Proficiency in Microsoft Word, Excel, and PowerPoint. Experience in the biopharmaceutical industry, a contract research organization, an academic research setting, or a public health environment is preferred. Experience in comparative effectiveness research, preferably in vaccinology, infectious diseases, influenza, or respiratory disease, is preferred. A publication record in peer-reviewed clinical, epidemiologic, health outcomes, or methodological journals is preferred. Ability to undertake up to 10% domestic and international travel. The expected base salary range for this position at hiring is $134,000 - $159,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity. #J-18808-Ljbffr CSL