15 ago
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Cv-Library
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España
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. 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. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. 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 interpretation.
Communicate complex quantitative concepts clearly to non‑statistical stakeholders—including sponsor leadership, regulatory representatives, and clinical teams.
Develop or provide senior oversight for statistical deliverables, including: statistical selection of protocols,
statistical analysis plans (SAPs), randomization specifications and statistical contributions to CSRs, publications, and regulatory documents.
Identify risks related to study design, sample size, or analysis approaches and proactively propose mitigation strategies.
Act as project manager for biostatistics stand‑alone work and drive high‑quality statistical deliverables while managing budget, scope, and timeline expectations.
Advise clients on regulatory guidelines, statistical principles for submissions, and general expectations (FDA, EMA, PMDA, etc.).
Act as an independent biostatistician on DSMBs and DMCs.
Advanced degree (MS or PhD) from accredited college or university in statistics or closely related field; equivalent combination of education, training and experience will be considered.
~15+ years’ experience in clinical trials design and analysis, preferably in a CRO environment.
~ At l
📌 Statistical Scientist Director (España)
🏢 Cv-Library
📍 España