Director, Regulatory Data

4 days ago

London, United Kingdom Novartis Farmacéutica Full time

Influences and drives statistical strategy/innovation at advanced expert-level directly taking part in cross-functional collaboration & decision making for multiple programs, across multiple indications/therapeutic/disease areas within (pre/early/full) clinical development and/or medical affairs. Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions.
We are investing in new technologies and building specific therapeutic areas and platform depth and capabilities – all to bring our medicines to patients even faster.
We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.
You will be required to influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) across (pre/early/full) clinical development and/or medical affairs. You will 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.
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).
Facilitate flawless transition of projects from early to full development. Plan, prioritize and oversee project level activities and ensure efficient resource management within development unit and effective partnership with external vendors.
Significantly contribute to project team preparation and play a prominent role representing Biostatistics at HA Advisory Committees and meetings.
MS Statistics or equivalent with 12+ years’ work experience or PhD (in Statistics or equivalent) with 8 years+ 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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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