Principal Statistician

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

Vantaggi offerti da questo lavoro

Hybrid/remote work

Descrizione del lavoro

Warman O'Brien in Milan seeks a Principal Biostatistician to shape clinical trial design and analysis across phases I–IV. You will partner with cross-functional teams and CROs, ensuring statistical rigor, regulatory readiness, and high-quality outputs.

The role demands leadership, mentoring, and strategic insights across development, regulatory, and medical affairs. Hybrid/remote work based in Italy offers flexibility for experienced professionals.

Competenze

• PhD in Biostatistics or MS with extensive clinical trials and pharma/CRO experience.
• Strong expertise in statistical methods for Phases I–IV and regulatory submissions.
• Excellent communication to translate complex data for non-statistical teams.

Mansioni

• Lead statistical strategy across trials from phase I to IV.
• Develop, review SAPs, protocols, study reports, and publications.
• Present data insights clearly to teams and regulators.
• Coordinate with CROs/vendors and ensure timely deliverables.
• Mentor junior statisticians and support knowledge growth.
• Ensure regulatory readiness of deliverables and inspections.
• Contribute to cross-functional development strategies.

Conoscenze

Statistical analysis

Regulatory knowledge

Mentoring

Formazione

PhD in Biostatistics

MS in Biostatistics or related

Strumenti

SAS

R

Python

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?