Contract Biostatistician

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. J-18808-Ljbffr

Location: Sassari, Sardegna, IT

Posted Date: 8/16/2025