DA
Daiichi Sankyo Europe
1 Monat

Biostatistics Director for Evidence Generation(m/w/x)

Management
Vollzeit
mit Homeoffice
Keine Angabe
München, Wien

As a Biostatistics Director, you will lead the biostatistical strategy for evidence generation, ensuring that all activities meet scientific and regulatory standards. This role involves overseeing a team, managing budgets, and collaborating with internal and external stakeholders to deliver high-quality statistical outputs.

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Anforderungen

  • Master's degree or PhD in statistics, mathematics, or related fields
  • At least 10 years of experience as statistician
  • Experience in late phase projects
  • Up-to-date knowledge of statistical methods related to clinical studies and HEOR/HTA applications
  • Knowledge of principles, concepts, methods, and standards of Clinical Research
  • Expertise in study design, conduct, and execution
  • Excellent English language skills
  • Excellent communication skills in explaining complex concepts
  • Demonstrated entrepreneurship, leadership, and proactive problem solving
Master-Abschluss
ODER
Doktor / Ph.D.

Berufserfahrung

10 Jahre

Deine Aufgaben

  • Lead biostatistical strategy for evidence generation
  • Oversee all biostatistical activities for Medical Affairs, HEOR, and HTA
  • Ensure scientific soundness of evidence generated for internal and external stakeholders
  • Act as project lead for deliverables from assigned biostatisticians
  • Serve as escalation point for statistical studies within the program
  • Lead critical studies from design to analysis execution
  • Ensure timely and accurate completion of statistical deliverables
  • Contribute to regulatory and pricing authority submissions
  • Participate in meetings with health authorities as a subject matter expert
  • Ensure compliance with international regulations
  • Prepare for audits and inspections related to assigned studies
  • Provide governance and oversight of vendor delivery
  • Manage budget activities within the area of responsibility
  • Lead and mentor a team, including recruitment and performance reviews
  • Lead cross-functional project teams
  • Initiate and participate in process improvement initiatives
  • Maintain knowledge of industry best practices in statistical methodology
  • Provide guidance to statistical team members as a subject matter expert
  • Partner with stakeholders to optimize statistical technology and processes

Sprachen

Englischverhandlungssicher

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