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Job Description & How to Apply Below
What You’ll Be Doing As a key member of the biostatistics team, you’ll: Lead the design of innovative clinical trials (Phases I–IV), ensuring they are efficient, scientifically robust, and aligned with strategic goals Develop and review key trial documentation: protocols, SAPs, CSRs, publications, and more Present statistical findings clearly and effectively to internal and external stakeholders Provide expert statistical input on regulatory submissions, publications, and responses to health authorities Oversee multiple studies within a therapeutic area, ensuring consistency, compliance, and quality Manage and maintain strong working relationships with CROs, vendors, and alliance partners Serve as the biostatistics point of contact across cross-functional project teams, contributing strategic insights throughout the drug development lifecycle Stay ahead of industry trends by applying statistical methodology to real-world evidence and market access initiatives Support audits and regulatory inspections, ensuring all deliverables are audit-ready and compliant with internal SOPs Direct reports across large team What We’re Looking For PhD in Statistics, Biostatistics, or a related field with 6+ years of industry experience – OR – MS with 8+ years Strong hands-on programming experience in SAS, R, or Python Proven ability to design and implement advanced statistical analyses across all clinical phases Solid understanding of regulatory frameworks.
Experience in Oncology or rare disease trials is highly desirable A collaborative mindset with excellent communication and leadership skills Ability to lead, mentor, and guide junior statisticians and cross-functional teams Why Join This Team? Work with a top-tier pharmaceutical company with a global footprint Be part of a collaborative, science-driven culture Influence projects from early development through to regulatory approval Enjoy flexibility with a hybrid / remote work model based in Italy Make a tangible impact on the future of medicine – especially in rare and complex diseases 💡 Ready to make a difference in your next role?
Let’s talk! Reach out to Aimee at to learn more or apply today.
Position Requirements
10+ Years
work experience
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