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Director Biostatistics Medical Affairs, Real World Data Expert
2 months ago
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. This role offers the opportunity to influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) in medical affairs.
Key Responsibilities- Lead and integrate input from different quantitative scientists impacting clinical development and health authority interactions.
- Represent the biostatistics function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions to the organization.
- 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. Also proposing and implementing 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.
- 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 with 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 the ability to mentor up to 10 associates.
Novartis is a global healthcare company that is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
