Associate Director, Global Auditing

2 giorni fa

Roma, Italia Warman O'Brien A tempo pieno

Associate Director / Director – Global Pharma Leader – Italy (Remote / Hybrid)
Our client, a globally renowned pharmaceutical company, is seeking a talented and experienced Associate Director / Director to join their high-impact team. 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 in SAS, 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 teams
Work with a top‐tier pharmaceutical company with a global footprint
Influence projects from early development through to regulatory approval
Enjoy flexibility with a hybrid / remote work model based in Italy

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