Associate Director Biostatistics

5 giorni fa


Rome, Italia Warman O'Brien A tempo pieno

Associate Director / Director – Global Pharma Leader – Italy (Remote /Hybrid)Are you ready to take the next big step in your biostatistics career?Our client, a globally renowned pharmaceutical company, is seeking a talented and experienced Associate Director / Director to join their high-impact team. If you thrive in a collaborative, fast-paced environment where your work directly contributes to ground-breaking treatments and improved patient outcomes, this could be your perfect fit.What You'll Be DoingAs 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 teamWhat 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 teamsWhy 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 diseasesReady to make a difference in your next role?Let's talk Reach out to Aimee at aimee@warmanobrien.com to learn more or apply today.



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