Director Biostatistics
- Global Program Biostatistics Head for a mid to high complexity project and/or Lead Statistician for multiple pre/early clinical/CP projects
- Individual contributor who is a thought leader in drug development biostatistics across related indications/areas within Novartis and across the external scientific/research community
- Ensure expert level contribution to strategy (design, analysis/synthesis, interpretation and reporting, health authority response, negotiating with health technology assessment (HTAs) organizations, influence and implement publication strategies, quantitative decision making) for critical clinical studies in a drug development program
- Accountable for strategic statistical input and influence into one or more drug development projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables).
- Lead collaborations with strategic functions within the global program teams (GPTs) 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 full development. Also proposing and implementing innovative designs and methods to optimize drug development life cycle.
- Plan, prioritize and oversee project level activities and ensure efficient resource management within development unit and effective partnership with external vendors.
- Represent Biostatistics and Pharmacometrics line function at internal and external decision boards.
- Significantly contribute to project team preparation and play a prominent role representing Biostatistics at HA Advisory Committees and meetings.
- Lead or significantly contribute to initiatives at global line function level, or cross-functional level and across external professional associations and consortia, requiring coordination of diverse team members with wide ranging technical and non-technical skill sets.
- MS Statistics or equivalent with work experience or PhD (in Statistics or equivalent) with work experience
- 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 and expertise of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas which may include exposure-response modelling 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
- Extensive knowledge of drug development and HA guidelines
- Strong understanding of at least one disease/therapeutic area (depending on the role: Oncology, Immunology, Cardio Renal Metabolic, or Neuroscience.)
- Proven leadership ability with excellent collaboration skills and ability to mentor and provide oversight for up to 10 associates.
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