Manager, Biostatistics (Associate Director) – Global Pharma Leader – Italy (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 Manager of Biostatistics 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 goalsDevelop and review key trial documentation: protocols, SAPs, CSRs, publications, and morePresent statistical findings clearly and effectively to internal and external stakeholdersProvide expert statistical input on regulatory submissions, publications, and responses to health authoritiesOversee multiple studies within a therapeutic area, ensuring consistency, compliance, and qualityManage and maintain strong working relationships with CROs, vendors, and alliance partnersServe as the biostatistics point of contact across cross-functional project teams, contributing strategic insights throughout the drug development lifecycleStay ahead of industry trends by applying statistical methodology to real-world evidence and market access initiativesSupport audits and regulatory inspections, ensuring all deliverables are audit-ready and compliant with internal SOPsWhat We’re Looking ForPhD in Statistics, Biostatistics, or a related field with 6+ years of industry experience – OR – MS with 8+ yearsStrong hands-on programming experience in SAS, R, or PythonProven ability to design and implement advanced statistical analyses across all clinical phasesSolid understanding of regulatory frameworks; experience with HTA is a plusExperience in rare disease trials is highly desirableA collaborative mindset with excellent communication and leadership skillsAbility to lead, mentor, and guide junior statisticians and cross-functional teamsWhy Join This Team?Work with a top-tier pharmaceutical company with a global footprintBe part of a collaborative, science-driven cultureInfluence projects from early development through to regulatory approvalEnjoy flexibility with a hybrid work model based in ItalyMake 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 aimee@warmanobrien.com to learn more or apply today.