Principal Statistician

Warman O'Brien; Milano; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Warman O'Brien is seeking a Principal Biostatistician (strong seniors considered) to shape drug development in a global pharmaceutical setting in Italy. You will lead statistical strategy across clinical trials and collaborate with cross-functional teams.

The role requires a PhD or MS with extensive experience, proficiency in SAS/R/Python, and regulatory know-how; you'll mentor juniors, coordinate CROs, and support inspections in a hybrid/remote Italian work model.

Competenze

• PhD or MS in Biostatistics or related field with extensive experience.
• Experience in pharmaceutical/ CRO environments desirable.
• Strong communication and regulatory readiness skills.

Mansioni

• Design and lead clinical trials (Phases I–IV) with clear endpoints.
• Develop and review SAPs, study reports and publication materials.
• Present data clearly to teams and regulatory bodies.
• Act as statistical lead across multiple studies and CROs.
• Mentor junior statisticians and support team knowledge growth.
• Ensure regulatory readiness of deliverables and audits readiness.

Conoscenze

SAS

R

Python

Clinical trials design

Cross-functional collaboration

Statistical analysis

Formazione

PhD in Biostatistics or related

MS in Biostatistics or related

Descrizione del lavoro

Principal Biostatistician (strong Seniors considered) – Global Pharma | Italy (Hybrid)

Shape the Future of Drug Development

Are you an experienced statistician ready to take your expertise to the next level? Our client, a leading international pharmaceutical company, is looking for a Principal Biostatistician to join their dynamic and collaborative team. If you're passionate about designing meaningful clinical trials and influencing global health outcomes, this is the opportunity for you.

What You’ll Be Doing

As a key statistical expert, you’ll play a pivotal role across all phases of clinical development—from strategy through execution. You’ll partner with cross-functional teams and external vendors to ensure the scientific integrity and success of clinical trials.

Your responsibilities will include:

• Designing innovative and efficient clinical trials (Phases I–IV), including defining study populations and endpoints aligned with key objectives.
• Leading the development and review of protocols, statistical analysis plans (SAPs), study reports, and publication materials.
• Presenting data and insights in a clear, concise, and transparent manner to internal teams and regulatory bodies.
• Serving as a statistical lead across multiple studies, ensuring high-quality, standardized outputs within a therapeutic area.
• Acting as a primary point of contact for CROs and vendors, managing Biostatistics deliverables end-to-end.
• Applying advanced statistical methodologies and ensuring regulatory readiness of all deliverables.
• Contributing strategic insights across clinical development, regulatory, market access, and medical affairs functions.
• Mentoring junior statisticians and supporting team knowledge growth.
• Preparing for and supporting Health Authority inspections and audits.

What We’re Looking For

• PhD (6+ years’ experience) or MS (8+ years’ experience) in Biostatistics, Statistics, or related field.
• Proven experience in the pharmaceutical industry or CRO environment.
• Strong proficiency in SAS, R, or Python.
• Deep understanding of statistical methodologies related to clinical trials and real-world evidence.
• Experience in rare disease is a plus.
• Familiarity with regulatory and HTA (Health Technology Assessment) processes is highly desirable.
• Strong communication skills, with the ability to translate complex data into actionable insights.

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 / remote 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?