Summary

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. Responsible for leading and integrating input from different quantitative scientists, impacting clinical development, health authority interactions. Represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions. -CDS -Supports Head CDS in setting the standards and automation strategy across Novartis. Manage a global team(s) responsible for executing data standards / automation objectives across DO. Responsible for ensuring quality, scalable, reusable, (CDISC and regulatory) compliant data standards and technologies are transparently deployed across GDO in close collaboration with external industry peers and internal stakeholders delivering stellar customer focus. Responsible for planning and overseeing KPIs/metrics, frameworks, policies, business rules and processes for development, maintenance, deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.

• 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 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
• Extensive knowledge of drug development and HA guidelines
• Strong understanding of at least one disease/therapeutic area.
• Proven leadership ability with excellent collaboration skills and ability to mentor and provide oversight for up to 10 associates.