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Sr Expert, Science & Technology (Principal CMC Statistician)


Information Technology


San Diego, California, United States

12,000. The number of associates worldwide working together to reimagine medicine! The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.<br><br>**The location of this position can be based in San Diego, CA / East Hanover, NJ / Durham, NC. A work location of San Diego, CA is highly preferred. Ability to work remotely 2 days a week, 3 days a week onsite is required.<br><br>Novartis is seeking a CMC statistical lead within the Quantitative Science and Statistics (QSS) function in Research and Development (R&D). The CMC statistical lead will be providing statistical expertise in support for broad activities within CMC domain across cell and gene therapies for pipeline programs. Collaborate and provide statistical input on broad CMC activities including but not limited to analytical method development, method qualification/validation, technology transfer/bridging, product specification, product stability, process improvement, process validation, process control and quality by design. Apply statistical principles and techniques to provide strategies and solutions to a wide range of challenging problems in the drug development environment. Build effective relationships with peers and managements across functions and organizations. Participate in development of departmental process and infrastructure, as well as cross-functional team activities.<br><br>Your responsibilities will include, but are not limited to:<br><br>• Provide strategic statistical leadership and expertise to CMC functions and project teams on the development and implementation of proper study design, statistical analysis and data interpretation. <br>• Lead statistical support for CMC projects and participate in reviewing and writing study protocol and technical reports.<br>• Support regulatory strategy and preparation of regulatory submissions such as IND and BLA and participate in meetings with regulatory agencies. <br>• Develop novel statistical methods to solve challenging issues in cell and gene therapies CMC domain.<br>• Participate in development of intra- and inter-department process and infrastructure. <br>• Design and conduct statistical trainings to non-statisticians.<br><br><br>[#video#{#400,300#}#/video#]<br><br>Vaccine Policy: While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to