Graduate degree (Master's or PhD) in public health, epidemiology, biostatistics, or related field; equivalent experience may be considered.
Minimum of three years in observational research or real-world evidence generation.
Strong understanding of Phase IV outcomes research and epidemiologic methods.
Experience with claims databases and conducting systematic literature reviews.
Proficiency in statistical programming using SAS, SQL, R, or Stata; R preferred.
Excellent communication skills for translating complex concepts into clear reports and presentations.
Demonstrated project-management expertise in a fast-paced environment.
Responsibilities
Manage Phase IV real-world evidence research for the influenza vaccine portfolio.
Serve as project manager and technical analyst for studies, making scientific and operational recommendations.
Develop and review study concepts, protocols, and statistical analysis plans.
Manage vendors and collaborators, ensuring high-quality work within timelines and budgets.
Conduct systematic literature reviews and meta-analyses to identify evidence gaps.
Review and interpret statistical analyses of real-world data according to research protocols.
Coordinate scientific dissemination through abstracts, presentations, and manuscripts.
Benefits
Comprehensive health and wellness programs.
Support for professional development and career growth.
Flexible work arrangements to promote work-life balance.
Diversity and inclusion initiatives fostering a supportive workplace culture.
Opportunities for domestic and international travel.
Full Job Description
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.
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
Watch our 'On the Front Line' video to learn more about CSL Seqirus
About CSL Limited
CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
