Associate Director, Global Auditing

5 giorni fa

Bologna, 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 experiencedAssociate Director / Directorto 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.Develop and review key trial documentation: protocols, SAPs, CSRs, publications, and more
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
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
Strong hands-on programming experience inSAS, R, or Python
Proven ability to design and implement advanced statistical analyses across all clinical phases
Solid understanding of regulatory frameworks.
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
Influence projects from early development through to regulatory approval
Enjoy flexibility with ahybrid / remote work modelbased in Italy

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