Principal Statistician

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

Descrizione del lavoro

Global Pharma in Italia, con modello ibrido, cerca un Biostatistico Principale (Senior attorno) per guidare studi clinici dall’ambito strategico all’esecuzione, collaborando con team interfunzionali e fornitori esterni.

Il candidato ideale possiede PhD o MS con solide esperienze nel settore farmaceutico/CRO e una forte padronanza di SAS, R o Python, nonché competenze regolatorie avanzate.

Competenze

• Dottorato di ricerca (PhD) in Biostatistica o disciplina correlata con esperienza rilevante.
• Possibilità di un MS con esperienza conforme (8+ anni).
• Competenze avanzate in SAS, R o Python e statistica clinica.

Mansioni

• Progetta studi clinici in Fasi I–IV (popolazioni, endpoint).
• Guida protocolli, SAP e report di studio.
• Presenta dati e intuizioni a team interni e enti regolatori.
• Assume ruolo di lead statistico su studi multipli e gestione fornitori CRO.
• Gestisce deliverables statistici end‑to‑end e qualità normativa.
• Contribuisce a insights strategici in sviluppo clinico, HTA e affari medici.
• Mede junior statistici e sostiene lo sviluppo del team.
• Supporta ispezioni e audit delle Autorità Sanitarie.

Conoscenze

Communication skills

Formazione

PhD in Biostatistics

MS in Biostatistics

Strumenti

SAS

R

Python

Descrizione del lavoro

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

Continui a leggere per scoprire di cosa avrà bisogno per avere successo in questa posizione, incluse competenze, qualifiche ed esperienza. 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.