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Director, Regulatory Data Strategy

2 months ago

London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time

Job Summary:

We are seeking a highly experienced and skilled Director, Regulatory Data Strategy to join our team at Advanced Accelerator Applications (Italy) - S.p.A. The successful candidate will be responsible for driving statistical strategy and innovation across multiple programs, collaborating with cross-functional teams, and providing strategic leadership and solutions.

Key Responsibilities:

  • Develop and implement statistical strategies for critical clinical studies, ensuring expert-level contribution to project design, analysis, interpretation, and reporting.
  • Provide strategic input and influence into one or more drug development projects, including development plans, dose-finding strategies, regulatory strategies, publication strategies, and pricing & reimbursement strategies.
  • Facilitate seamless project transitions from early to full development, proposing and implementing innovative designs and methods to optimize the drug development lifecycle.
  • Plan, prioritize, and oversee project-level activities, ensuring efficient resource management and effective partnerships with external vendors.
  • Contribute to project team preparation and represent Biostatistics at HA Advisory Committees and meetings.

Requirements:

  • Master's degree in Statistics or equivalent, with 12+ years of work experience, or PhD in Statistics or equivalent, with 8+ years of work experience.
  • Fluent in English, with strong communication and presentation skills, and the ability to articulate complex concepts to diverse audiences.
  • Expert knowledge in statistical areas, including exposure-response modeling, applied Bayesian statistics, exploration of high-dimensional data, and complex innovative designs.
  • Record of successful implementation of novel methods and/or innovative strategies in drug development.

Why Join Us:

At Advanced Accelerator Applications (Italy) - S.p.A., we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.