Director Biostatistics Medical Affairs, Real World Data Expert

6 days ago


London, Greater London, United Kingdom Novartis Farmacéutica Full time
About the Role

We are seeking a highly skilled and motivated individual to join our team as Director Biostatistics supporting Medical Affairs as a Real World Data Expert at Novartis Farmacéutica.

Key Responsibilities
  1. Lead and integrate statistical strategy and innovation for program(s) medical affairs, influencing cross-functional collaboration and decision making.
  2. Represent the biostatistics function at internal and external decision boards, developing and mentoring other statisticians.
  3. Provide strategic, technical, operational, and scientific leadership and solutions to the organization.
Requirements
  1. Expert level contribution to strategy for critical studies in a program, with emphasis on analysis and interpretation of Real World Data.
  2. Accountable for strategic statistical input and influence into one or more projects, including development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables, and Real World Data.
  3. Lead collaborations with strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans.
  4. Facilitate flawless transition of projects from early to late development, proposing and implementing innovative designs and methods to optimize drug development.
  5. Plan, prioritize, and oversee project level activities, ensuring efficient resource management within or across franchise and effective partnership with vendors.
  6. Represent Biostatistics and Pharmacometrics line function at internal and external decision boards.
  7. Lead or significantly contribute to initiatives at global line function level, or cross-functional franchise level, requiring coordination of diverse team members.
Qualifications
  1. 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.
  2. Fluent in English with strong communication and presentation skills, with the ability to articulate complex concepts to diverse audiences.
  3. Influences decisions that directly impact the project and department's ability to deliver objectives.
  4. Has advanced knowledge of applying statistics and innovative approaches, with expert knowledge in a variety of statistical areas.
  5. Record of successful implementation of novel methods and/or innovative strategies in drug development.
  6. Extensive knowledge of drug development and Health Authority guidelines.
  7. Strong understanding of at least one disease area.
  8. Proven leadership ability with excellent collaboration skill and ability to mentor up to 10 associates.


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