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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 will be responsible for influencing and driving statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) medical affairs.
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. 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 ability to mentor up to 10 associates.
At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We are a global healthcare leader dedicated to discovering new medicines that change patients' lives. We are seeking talented individuals who share our passion for innovation and our commitment to excellence.
