Principal Statistician

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?
Let's talk! Reach out to

Aimee at Visualizzare la mail su click.jobroute.io

to learn more or apply today.