Contract Biostatistician

Warman O'Brien; Venezia; Ibrido; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A leading global biopharmaceutical organisation is seeking an experienced Contract Biostatistician. This role offers remote or hybrid options in Italy or Belgium. You will be involved in all phases of clinical research, work across multiple therapeutic areas, and contribute to regulatory submissions. Candidates should have an MSc or PhD in Biostatistics and 5+ years of experience in clinical trials. Join a collaborative team and engage in diverse projects for submission-ready studies.

Servizi

Flexible working model

Diverse and meaningful projects

Opportunity to work on submission-ready studies

Competenze

• 5+ years of relevant experience in clinical trials (pharma, biotech, or CRO).
• Strong understanding of statistical methodology and regulatory frameworks.
• Previous experience with HTA, PK/PD data, or regulatory submissions is a plus.

Mansioni

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

Conoscenze

Statistical analysis

Communication

Stakeholder engagement

Clinical trial design

SAS proficiency

Formazione

MSc or PhD in Biostatistics/Statistics

Strumenti

SAS

R/S-Plus

CDISC standards

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 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.