Director Biostatistics Medical Affairs Expert

6 hours ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
Job Title: Director Biostatistics Medical Affairs Expert

Novartis is seeking a highly skilled and motivated individual to join our team as a Director Biostatistics Medical Affairs Expert. This role offers hybrid working, requiring 3 days per week or 12 days per month in our London Office.

Key Responsibilities:
  • Ensure expert-level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with pricing agencies, influence and implement publication strategy, quantitative decision making) for critical studies in a program, with emphasis on analysis and interpretation of Real World Data.
  • Accountable for strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables, Real World Data).
  • Lead collaborations with strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
  • Facilitate flawless transition of projects from early to late development. Propose and implement innovative designs and methods to optimize drug development.
  • Plan, prioritize and oversee project-level activities and ensure efficient resource management within or across franchise and effective partnership with vendors.
  • Represent Biostatistics and Pharmacometrics line function at internal and external decision boards (e.g. regulators).
  • Lead or significantly contribute to initiatives at global line function level, or cross-functional franchise level, requiring coordination of diverse team members.
Requirements:
  • MS Statistics or equivalent with 12+ years' work experience or PhD (in Statistics or equivalent) with 8 years+ work experience with expertise in Real World Data analysis methodology.
  • Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
  • Influences decisions that directly impact the project and department's ability to deliver objectives.
  • Has advanced knowledge of applying statistics and innovative approaches; expert knowledge in a variety of statistical areas.
  • Record of successful implementation of novel methods and/or innovative strategies in drug development.
  • Extensive knowledge of drug development and Health Authority guidelines.
  • Strong understanding of at least one disease area.
  • Proven leadership ability with excellent collaboration skills and ability to mentor up to 10 associates.
Why Novartis:

At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We believe that our employees are our greatest asset, and we strive to create a workplace that is inspiring, challenging, and rewarding.



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