Senior Biostatistics Lead

hace 1 semana

Madrid Centro, Madrid, España Ergomed Group A tiempo completo
Job Summary

We are seeking a highly skilled Senior Biostatistics Lead to join our team at Ergomed Group. As a key member of our Biostatistics department, you will be responsible for leading the design, analysis, and interpretation of clinical studies.

Key Responsibilities
  1. Study Leadership: Serve as a lead statistician for multiple studies, clinical programs, integrations, submissions, adaptive designs, and other complex studies.
  2. Statistical Oversight: Provide review and oversight to statistical output created by other members of the biostatistics department.
  3. Consultative Support: Provide consultative support to sponsors and/or internal teams regarding topics of study design, exploratory analyses, statistical methods, and other relevant topics.
  4. Regulatory Representation: Represent sponsors in regulatory meetings.
  5. Presentations: Present relevant statistical output and findings to Safety Review Committees (and other similar bodies).
  6. Qualification Audits: Represent biostatistics in qualification audits, study audits, and other pre-trial assessment activities.
  7. Sales Support: Represent the function in bid defenses and other sales-related activities such as review of RFP content; including input to the budget, suggestions related to study design, and other contributions to the opportunity strategy.
  8. Process Improvement: Lead initiatives and process improvement activities on behalf of management.
  9. Strategic Support: Support the head of Biostatistics (and as needed, Head of Biometrics) on topics related to statistical issues, process improvement, industry trends, and other relevant topics.

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