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Contract biostatistician

Pisa
Warman O'Brien
Pubblicato il Pubblicato 20h fa
Descrizione

Contract Biostatistician – Remote (Europe)

Remote/Hybrid – Italy or Belgium (Flexible Location)

6–12 Month Contract | Competitive Day Rate

A leading global biopharmaceutical organisation 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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