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 escalate 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.
About CSL Seqirus CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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