Statistician

The Statistician supports TS/MS for current and new products and processes, driving and sustaining statistical thinking and appropriate use of statistical methodologies. Specific aspects include (but not limited to) statistically designed experiments, sampling, stability, packaging, establishment of regulatory specs, evaluation of control/capability, process/analytical method validation/transfers and developing and providing Statistical training.Primary responsibilities:Apply analytical and statistical methodology, including the concepts of Statistical Process Control (SPC), to process and experimental data to identify trends, assess process capability, and provide appropriate conclusions to enable data-driven decision-making and to determine the root cause of process upsets.Provide statistical expertise, study design, and analysis and communicate data-driven decisions for process improvements, process understanding, method development and validation, assay transfer, and stability studies in collaboration with personnel supporting all aspects of manufacturing.Establish control strategies for manufacturing processes and analytical assays. Use appropriate statistical methodologies to assign specifications, validation acceptance criteria, tech transfer criteria, material sampling criteria, comparability assessments and analysis of batch data for summary reports and product reviews.Maintain statistical expertise by learning new methodologies, choosing which methods to use in analysis, and justifying methods selected.Use of statistical and programming software (e.g. SAS, R, JMP, Python, SIMCA) to apply a broad range of data science and statistical applications, such as linear regression, DoE, multivariate analysis, and statistical modeling.Develop and administer training courses for various statistical methods and software, including planning and leading workshops to help facilitate statistical thinking across the various functional areas.Communicate study results and statistical concepts in one-on-one meetings, oral presentations, internal reports, and presentations at professional association meetings.Work in a highly fluid environment with rapidly changing priorities providing statistical guidance and problem-solving acumen to diverse teams.Ensure data integrity by performing rigorous error checking, and data validation.Attributes for the Role:A demonstrated interest in the field of statisticsSkilled in quantitative analysis and data managementStrong problem-solving skillsDemonstrable learning agilityStrong ability to influenceEducational/Experience Requirements:MSc in Statistics with >3 years' experience or equivalentProficiency in the use of statistical software (e.g. JMP, SAS, R, S-Plus, etc.)Prior experience in a pharmaceutical manufacturing environment is preferable.

#J-18808-Ljbffr