Senior Applied Statistician
Core
Apply industrial statistics to improve manufacturing control, reduce process variation, and ensure regulatory compliance in biologics production.
Role type
Senior Applied Statistician (Manufacturing/Process Control)
Builds
Real-time and offline control charts, data collection plans, measurement system analyses, and experiment designs for process optimization.
Domain
Biologics manufacturing / Industrial Statistics / Process Control
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Industrial statistics, Control chart design, Process capability analysis, Experimental design (DoE), Multivariate statistical process control (MSPC), Hotelling's T², Measurement system analysis, Six Sigma methodologies, Statistical software (R, Python, TIBCO Statistica, SIMCA, Minitab), Cloud computing, Git, Containers, DevOps practices
Preferred skills
None explicitly stated
Technologies
R, Python, TIBCO Statistica, SIMCA, Minitab, Cloud platforms, Git, Container orchestration tools
Responsibilities
Lead GMP statistical strategies for manufacturing process monitoring, Design and manage real-time and offline control charts for critical quality parameters, Analyze process performance using advanced data methods to evaluate capability and trends, Identify variation sources and partner with teams to improve process robustness, Design data strategies including measurement system analyses and experiment designs, Ensure alignment of data and validation activities with FDA and ICH guidelines, Train global statisticians and site workers in statistical thinking
Seniority
Senior, hands-on IC