Associate Director Biostatistics

Overview

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 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

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 with HTA is a plus
• Experience in 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 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 aimee@warmanobrien.com to learn more or apply today.