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(senior) biostatistician (f/m/d)

München
Arthrex GmbH
Biostatistician
Inserat online seit: 27 Januar
Beschreibung

Overview In line with Arthrex’s mission of helping surgeons treat their patients better, our global Research team generates the scientific evidence behind our innovative products and techniques. To support this work, we are seeking a Senior Biostatistician to join us in Munich. In this standalone expert role, you will serve as a key statistical resource across clinical, biomechanical, and biomedical research. This highly collaborative position plays a central role in ensuring scientific rigor and translating data into evidence that supports product adoption and meaningful patient outcomes. Senior Biostatistician (f/md) Responsibilities Lead as the statistical expert for the Arthrex Research team, shaping study design, and evidence planning across cross-functional teams Serve as 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-model, 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 statistical subject matter expert across the Research department Qualifications Master's degree (or equivalent) in Biostatistics, Statistics, or a related field; PhD preferred High 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., registry, real-world data, observational datasets) is strong positive Collaborative mindset and capability to work effectively in cross-functional, global teams Strong written and verbal communication skills in both English and German #J-18808-Ljbffr

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Festanstellung
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80.000 € pro Jahr
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