200+ compounds in Novartis are supported by biostatisticians in 10+ sites around the globe. Biostatisticians transform clinical data into analyses that build the basis for making innovative drugs accessible for patients. They influence decision-making in cross-functional international teams from early to late phase drug development.
As the Director Biostatistics, you will influence and drives statistical strategy/innovation directly taking part in cross-functional collaboration and decision making for program(s) within (pre/early/full) clinical development and/or medical affairs. You will lead and integrate input from different quantitative scientists impacting clinical development, 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.
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 pro jects (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 cross-functionally (e.g. data management, statistical programming, medical writing) to ensure timeliness and quality of statistical deliverables * Propose and implement innovative designs and methods to optimize drug development. * Plan, prioritize and oversee project level activities and ensure efficient re source management within or across franchise and effective partnership with vendors. * Lead the review and implementation of health authority guidances. * Represent biostatistics in interacting with external experts (statistical, clinical, and technical).