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About this job
Key facts
Job Title
Senior Biostatistician
Role type
Temporary
Start date
ASAP
Remote friendly
Yes
Location
Belgium
Salary
US$100 - US$105 per hour US$
We are supporting a global medical devices organisation operating in a highly regulated healthcare environment, currently strengthening its Biostatistics & Data Management function.
The organisation is seeking a Senior Biostatistician to play a pivotal role in defining, executing, and delivering statistical strategy across clinical studies, regulatory submissions, and post‑market activities.
This is a senior, high‑visibility role combining hands‑on statistical leadership with strong cross‑functional collaboration.
Responsibilities
- Lead statistical and analytical activities across all phases of clinical studies (pre‑ and post‑market).
- Design and independently execute statistical analysis plans, taking ownership of study strategy and methodology.
- Provide guidance on statistical standards, processes, and technical direction within the biostatistics team.
- Review clinical study protocols and Case Report Forms (CRFs) from a statistical perspective.
- Supervise randomisation schemes, unblinding activities, and appropriate handling of unblinded data.
- Lead the assessment of protocol deviations and their impact on statistical analyses.
- Produce high‑quality statistical reports for internal clinical documentation and regulatory submissions.
- Act as a statistical consultant to clinical, regulatory, data management, and business stakeholders.
- Contribute to peer‑reviewed publications and support manuscript development with clinicians and surgeons.
- Oversee statistical deliverables from junior biostatisticians and external vendors.
- Stay current with evolving statistical methodologies in clinical trial design and analysis.
Profile
- PhD in Statistics or a closely related field (mandatory).
- Minimum 4 years of experience performing statistical analyses in a regulated environment (FDA, GCP or equivalent), preferably within medical devices or healthcare.
- Strong background in clinical trial statistics.
- Solid expertise in:
- Descriptive and inferential statistics
- Survival analysis and longitudinal data analysis
- Covariate and multivariate analyses
- Bayesian statistics and meta‑analyses
- Proficient in SAS; familiarity with additional statistical tools for power analyses and smaller datasets is an advantage.
- Excellent written and verbal communication skills, with the ability to explain complex statistical concepts to non‑statistical audiences.
- Demonstrated leadership capabilities and experience guiding junior statisticians or external partners.
Project / Environment
- Function: Biostatistics & Data Management
- Location: Flemish Brabant
- Environment: Highly regulated (FDA, GCP and related standards)
- Focus: Clinical trials, regulatory submissions, quality initiatives, and scientific publications
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Hybrid working arrangement: on average 2-3 days per week on site, remainder remote.
To find out more about Real please visit www.realstaffing.com
