Expert TA Statistician

Welcome to Novartis - the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.The Expert TA Statistician can assume the role of an Independent Program Statistician for the assigned clinical development projects, or a mega trial1. Be the statistical leader and project manager for all CIS deliverables globally for- a clinical development program, or- mega trial.2. Ensure that clinical development programs (or parts assigned) e.g. managing overall publication programs for a very large, complex project) meets scientific, regulatory, quality, and commercialization requirements, through interaction with the IPT and ICT.3. Perform matrix management of CIS project team, and mentor staff as required.4. Ensure ECD-Bios, and modeling and simulation contribution is fully integrated into the project. 5. Plan and track project level activities for CIS, including resources.6. Establish and maintain project standards (master analysis plan, full development project specifications).7. Plan and manage submission activities, like SCS, SCE, briefing books (and/or publication activities for a very large, complex project).8. Participate in/lead non-clinical project activities.9. Interact with Health Authorities and external consultants as appropriate. Support and defend analyses and their interpretation at Health Authority Meetings. Represent Biostatistics at FDA Advisory Committee meetings (and/or interact with clinical leaders and external experts for leading statistical support for publications of a very large, complex project)10. Could take Trial Statistician responsibility as appropriate.QualificationsAt least Masters Degree (or equivalent degree) with 7 years of experience or PhD with 4 years of experience- Fluent in English (oral and written)- Experience in all tasks of program statistician- Proven knowledge and expertise in statistics and its applications to clinical trials in at least one Ta. Solid knowledge and experience in drug development process and HA guidelines.- Background medical knowledge, preferably in relation to the specific thereapeutic area.- Good knowledge of statistical software packages.- Possess Very good project management skills.- Effective communication and presentation skills.- Ability to give effective guidance to Trial Statisicians and Program Programmer.- Good team player- Good leadership skills. Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.