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    Senior Biometrician/ Biostatistician (m/f/d)

    from:
    medac is a dynamic company that has been growing continuously for over fifty years. More than 2,000 employees work on the further development of medical products and medical devices for the diagnosis and treatment of oncological, urological and autoimmune diseases. We are one of the leading pharmaceutical companies, in particular in the field of niche products.
    • Statistical responsibility for the efficient design of Global Clinical Development Programs using modern statistical methodologies
    • Defending the statistical approach at regulatory agencies such as EMA, FDA, PMDA, Anvisa etc.
    • Providing statistical expertise for early clinical development
    • Statistical responsibility for the design, protocol writing, analysis and reporting of clinical trials in phases I to III and multiple therapeutic areas
    • Conduct of the ICH-GCP-required oversight for outsourced clinical trials
    • Participation in Due Diligences to evaluate new product opportunities
    • Collaboration with our statistical programming team to prepare CDISC-compliant submission packages
    • Provide statistical support and consultancy for other medac departments such as Medical Affairs, Market Access, Pharmaceutical Development, Pharmacology & Toxicology
    • Degree in statistics, biometrics or mathematics with profound experience in medical issues.
    • At least 5 years of professional experience as a statistician in clinical research in a pharmaceutical company (sponsor)
    • Good knowledge of the available statistical methodology to be applied in Phase I to III in haematology, oncology and autoimmune diseases
    • Special knowledge in multiple testing procedures, time-to-event methods, adaptive clinical trials and pharmacometrics
    • Structured working method
    • High cooperation and team-work ability 
    • Fluency in English and German
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