Manager, CORE

CSL; Quebec; On-site; CAD 110,000 - 140,000; Full time

Job summary

CSL Seqirus in Canada seeks a senior epidemiology scientist to lead Phase IV real-world evidence studies across the influenza vaccine portfolio. You will coordinate internal and external studies, provide scientific and methodological recommendations, and manage timelines and budgets.

The ideal candidate has a graduate degree in public health or epidemiology, 3+ years in observational research, and strong communication and project-management skills.

Qualifications

• Graduate degree (Master’s or PhD) in public health, epidemiology, biostatistics, or related field.
• Minimum of three years of observational research or real-world evidence experience.
• Strong understanding of Phase IV outcomes research and epidemiologic methods.
• Experience with claims data, EHRs, registries, and meta-analyses.
• Programming experience in SAS/SQL/R; R preferred.
• Excellent written and oral communication skills.
• Proven project-management ability to handle multiple priorities.
• Ability to collaborate in a global, matrixed environment.
• Proficiency in MS Word, Excel, and PowerPoint.
• Experience in biopharma or CRO settings is preferred.
• Travel up to 10%.

Responsibilities

• Provide technical leadership for Phase IV real-world evidence studies on influenza vaccines.
• Serve as project manager and advisor for internal/external studies; offer scientific and operational recommendations.
• Develop protocols, SAPs, study reports, and evidence summaries.
• Manage vendors/CROs; monitor timelines and budgets; address risks to ensure quality within timelines.
• Conduct literature reviews and meta-analyses to identify evidence gaps and support plans.
• Review and analyze real-world data per approved protocols.
• Coordinate dissemination through abstracts, congress presentations, manuscripts, and journal submissions.
• Stay abreast of literature and trends; identify process improvements.
• Participate in CORE, Medical Affairs, and cross-functional teams.
• Ensure compliance with reporting standards and regulations (STROBE, ClinicalTrials.gov, IRB).
• Maintain quality standards and risk management across studies.

Skills

Public health

Epidemiology

Biostatistics

Study design

Project management

SAS

SQL

R

Communication

Collaboration

Travel readiness

Education

Master’s or PhD in public health/epidemiology/health outcomes

Tools

SAS

SQL

R

Stata

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 toEscalate 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 ofCSL. As one of the largest influenza vaccine providers in the world, CSL Seqirusis 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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus