Statistical Scientist Director

12 ago - Roma
Premier Research

Premier Research is looking for a Statistical Scientist Director to join our Biostatistics team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.Your ideas influence the way we work, and your voice matters here.As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.Join us and build your future here.What You'll Be Doing:Serve as lead statistician on complex, key client studies, acting as point-of-contact, ensuring cohesive communication with sponsors and internal teams, and leading project-level statistical strategy from protocol/SAP planning through reporting, ensuring alignment of design, analyses,



and data complex quantitative concepts clearly to non-statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams.Develops sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.Develops or provides senior oversight for statistical deliverables, including: statistical selection of protocols, statistical Analysis Plans (SAPs), randomization specifications and Statistical contributions to CSRs, publications, and regulatory documentsIdentify risks related to study design, sample size, or analysis approaches and proactively propose mitigation as project manager for biostatistics stand-alone work and drive high-quality statistical deliverables while managing budget, scope, and timeline clients on regulatory guidelines, statistical principles for submissions, and global expectations (FDA, EMA, PMDA, etc.).Support business development

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