About the roleThe Statistics Sr/Manager leads the CMC Statistics team, which is one of the primary groups within the CMC Data and Advanced Analytics COE. This position supports the statistical needs of nonclinical groups through managing the CMC Statistics team's day-to-day work and tactical projects, while ensuring the COE's strategic goals are achieved. This is a remote position.Responsibilities include but are not limited toManage our team of CMC statisticians, lead and coordinate statistical efforts throughout CMC.Provide sound strategic, scientific, and statistical input to the CMC Statistics team in support of ongoing and future work in nonclinical research and development projects, including: Design of experiments and use of appropriate statistical methodology and sample size.Preparation of statistical analysis plans; analysis of experimental and historical data.Creation of design of experiments and performance of various types of statistical analyses to develop predictive models and optimize conditions for processes, methods, and drug product/drug substance storage.Performing stability analysis to identify degradation rates and expiration dates.Preparing the statistical section of technical reports and presentations.Engaging in discussions and research to ensure the central place of applied statistics in research, development, quality, and validation projects.Ensure multiple projects are managed effectively to meet internal customers' deadlines with high-quality standards.Explain statistical designs and concepts to internal customers.Responsible for ensuring the administrative tasks for the CMC Statistics team are completed in a timely manner.Minimum requirementsA degree in Statistics/Biostatistics, Bioengineering, Chemical Engineering, or a related fieldFor the Manager level: BS degree with 9+ years of industry, or Master's degree with 6+ years of industry experience, or PhD degree with 4+ years of industryFor the Sr Manager level: BS degree with 12+ years of industry, or Master's degree with 9+ years of industry experience, or PhD degree with 7+ years of industryPrevious experience in managing a team of CMC StatisticiansSound knowledge of theoretical and applied statistics, preferably with emphasis on experimental design in biotechnology, statistical process control, analytical method development, process characterization, formulation development, stability, power calculations, etc.Hands-on experience using and scripting statistical software packages, including JMPFamiliarity with ICH guidelinesExperience in the drug development field is preferredEffective and proactive leader; team player; able to thrive in a fast-paced team environment and work independently on projectsExcellent interpersonal, oral, and written communication skillsMentorship ability to influence team members and communicate statistical concepts across functions
