Manager, CORE

Role overview

Research and project responsibilities

• Manage Phase IV real-world evidence studies and serve as project manager and technical analyst for internal and external projects.
• Develop and review study concepts, protocols, statistical analysis plans, study reports, and internal evidence summaries.
• Manage vendors, CROs, database partners, academic collaborators, and investigators; coordinate deliverables and address study risks.
• Conduct literature reviews, evidence summaries, and meta-analyses; review, interpret, and where appropriate perform statistical analyses.
• Coordinate abstracts, conference presentations, manuscripts, journal submissions, author input, reviewer responses, and scientific exchange materials.
• Maintain knowledge of relevant literature, methods, reporting standards, authorities, and emerging research approaches; identify process improvements.
• Contribute to evidence strategy, regulatory and medical responses, and internal decision-making; participate in cross-functional teams and collaborate with research partners.
• Ensure compliance with reporting and quality standards, STROBE, ClinicalTrials.gov registration, IRB requirements, applicable regulations, and company policies.

Qualifications

• Master’s or PhD in public health, epidemiology, biostatistics, pharmacoepidemiology, health outcomes research, or a related discipline; equivalent relevant experience may be considered.
• At least three years of relevant experience in observational research, real-world evidence, epidemiology, health outcomes research, or statistical programming with clinical, claims, registry, or EHR data.
• Strong knowledge of Phase IV outcomes research, observational design, real-world evidence, epidemiologic methods, comparative effectiveness, causal inference, confounding control, and vaccine effectiveness.
• Experience with real-world data sources, systematic literature reviews, and meta-analyses.
• Experience programming and reviewing statistical analyses using SAS, SQL, R, Stata, or similar software; R experience is preferred.
• Excellent oral and written communication; demonstrated project-management expertise and ability to manage priorities, timelines, budgets, quality, and ambiguity.
• Ability to build relationships and collaborate in a global, highly matrixed environment; proficiency in Microsoft Word, Excel, and PowerPoint.
• Biopharmaceutical, CRO, academic, or public health experience; comparative effectiveness experience in relevant disease areas; and peer-reviewed publications are preferred.

Travel

• Ability to undertake up to 10% domestic and international travel.

About CSL Seqirus