Contract Biostatistician
Descrizione dell'offerta
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.