Contract Biostatistician

Warman O'Brien; Veneto; Remoto; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A global biopharmaceutical organization is seeking an experienced Contract Biostatistician for a remote role in Italy. This position involves acting as a project-level statistician for clinical trials, leading statistical planning and analysis, and collaborating with various teams. The ideal candidate will have significant experience in clinical trials, a strong understanding of statistical methodologies, and be fluent in English. A flexible working model is offered.

Servizi

Flexible working model

Engage in diverse and meaningful projects

Opportunity to work on submission-ready studies

Competenze

• 5+ years of relevant experience in clinical trials (pharma, biotech, or CRO environment).
• Strong understanding of statistical methodology and regulatory frameworks.
• Fluent in English.

Mansioni

• Act as project-level statistician for clinical trials from Phase I–IV.
• Lead or support statistical planning and analysis for studies.
• Collaborate with internal departments and external vendors.

Conoscenze

Clinical trial design

Statistical analysis

SAS

Communication skills

Stakeholder engagement

Formazione

MSc or PhD in Biostatistics / Statistics

Strumenti

SAS

R / S-Plus

Descrizione del lavoro

Contract Biostatistician – Remote (Europe)

Remote / Hybrid – Italy or Belgium (Flexible Location)

6–12 Month Contract | Competitive Day Rate

A leading global biopharmaceutical organization is seeking an experienced Contract Biostatistician to support clinical development programs across multiple therapeutic areas.

This role offers the chance to play a key part in all phases of clinical research, working cross-functionally with biometrics, clinical operations, medical affairs, regulatory, and external vendors.

Key Responsibilities :

• Act as project-level statistician for clinical trials from Phase I–IV
• Lead or support statistical planning, analysis, and interpretation for studies
• Create and review statistical analysis plans (SAPs), mock shells, and randomisation schemes
• Perform or oversee analysis, validation, and statistical reporting for clinical data
• Collaborate with internal departments (data management, programming, clinical ops) and external vendors
• Contribute to regulatory submissions (e.G., FDA, EMA) and support response to statistical queries
• Provide input for publications, posters, and conference presentations

Requirements :

MSc or PhD in Biostatistics / Statistics or related field

5+ years of relevant experience in clinical trials (pharma, biotech, or CRO environment)

Strong understanding of clinical trial design, statistical methodology, and regulatory frameworks

Proficient in SAS; knowledge of R / S-Plus and CDISC (SDTM, ADaM) standards desirable

Excellent communication, documentation, and stakeholder engagement skills

Previous experience with HTA, PK / PD data, or regulatory submissions (BLA / NDA / MAA) is a plus

Fluent in English

Why apply?

Join a collaborative global biometrics team

Flexible working model – remote or hybrid

Engage in diverse and meaningful projects

Opportunity to work on submission-ready studies

Interested?

Apply now to explore this exciting opportunity, or get in touch directly to learn more.

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