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Director Biostatistics Medical Affairs, Real World Data Expert
3 months ago
Summary
Biostatistics 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 and 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 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, and deployment. Responsible to ensure Novartis fulfills a ROI across the standards and automation landscape.
About the RoleOur Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives. To do this, we are optimizing and strengthening our processes and ways of working. 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. Apply today and welcome to where we thrive together
The Role:
Are you ready to take your career in biostatistics to the next level? Novartis is seeking a highly skilled and motivated individual to join our team as Director Biostatistics supporting Medical Affairs as a Real World Data Expert. You will be required to influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) medical affairs. Responsible for leading and integrating 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.
Your Experience:
- 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 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.
Key requirements:
- 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.
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
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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