Overview As the Director/Sr Biostatistics, you will influence and drive statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) across multiple indications/therapeutic/disease areas within drug development. You will lead and integrate input from different quantitative scientists impacting clinical development, health authority interactions, represent the Advanced Quantitative Sciences 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. 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 Strategic statistical input and influence into one or more projects (development plan, dose-finding strategy, regulatory strategy, publication strategy, pricing & reimbursement strategy, statistical deliverables). Lead collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making in drug development and enable successful impact on robust drug development plans Collaborate across functions to ensure timeliness and quality of statistical deliverables Propose and implement innovative designs and methods to optimize drug development. Represent all functions within Advanced Quantitative Sciences (Biostatistics, Pharmacometrics, Statistical Programming) at project meetings Plan, prioritize and oversee project level activities and ensure efficient resource management within or across franchise and effective partnership with vendors. Lead the review and implementation of health authority guidance. Represent biostatistics in interacting with external experts (statistical, clinical, and technical). Essential Requirements MS (in Statistics or equivalent) with 12+ years relevant work experience or PhD (in Statistics or equivalent) with 8+ years relevant work experience Has advanced knowledge of applying statistics and innovative approaches Expert knowledge in a variety of statistical areas Experience in outcome trials Record of successful implementation of novel methods and/or innovative strategies in drug development Extensive knowledge of drug development and HA guidelines Strong understating of at least one disease area Fluent English (oral and written) Strong interpersonal and communication skills bridging scientific and business needs Desirable Requirements Proven people leadership ability and expert skills in building partnerships and collaborations. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $185,500.00 - $344,500.00 Skills Desired Automation, Biostatistics, Clinical Trials, Computer Programming, Cross-Functional Teams, Data Analytics, Data Strategy, Decision Making Skills, Global Project Management, Metadata Management, Statistical Analysis #J-18808-Ljbffr Healthcare Businesswomen’s Association
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