Senior Biostatistician – f/m/d
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Munich • Germany
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Job Level
Tech Stack
About the role
- Act as the statistical lead for the Arthrex Research team, shaping study design and evidence planning across cross-functional teams
- Serve as the primary statistical authority for Clinical Research, providing expert guidance with minimal oversight
- Design and guide impactful research—from defining endpoints and sample sizes to developing protocols and comprehensive Statistical Analysis Plans
- Drive advanced analytics and deliver submission-ready reports in full compliance with local and global standards (ICH, FDA, ISO, GCP, and MDR)
- Champion data integrity, collaborating with data management to optimize collection systems and ensure quality
- Conduct statistical analyses using R, SAS, Python or equivalent tools; apply appropriate statistical models including mixed models, categorical, Bayesian, and multivariate approaches as appropriate
- Translate insights into action, presenting results in reports, publications, and briefings, and making complex concepts clear for diverse stakeholders
- Mentor and guide junior or non-statistical personnel, acting as the statistical subject matter expert across the Research department
Requirements
- Master’s degree (or equivalent) in Biostatistics, Statistics, or a related field; PhD preferred
- Extensive experience in the medical device or pharmaceutical industry
- Proven proficiency in statistical programming (R, SAS, Python)
- Experience with regulatory statistical submissions and applicable standards (FDA, MDR, ISO, ICH, etc.)
- Experience with medical device clinical research (preferred)
- Experience with additional data sources (e.g., registries, real-world data, observational datasets) is a strong plus
- Collaborative mindset and ability to work effectively in cross-functional, global teams
- Strong written and verbal communication skills in both English and German.
Benefits
- Motivating and appreciative work environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical analysisstudy designevidence planningstatistical programmingmixed modelscategorical modelsBayesian modelsmultivariate approachesdata integrityregulatory statistical submissions
Soft Skills
mentoringcollaborationcommunicationcross-functional teamworktranslating insightsguidanceleadershipproblem-solvingadaptabilityclarity in presentation
Certifications
Master’s degree in BiostatisticsMaster’s degree in StatisticsPhD in BiostatisticsPhD in Statistics