Principal Statistician
Core
Apply statistical techniques and advanced analytics to optimize non-clinical development plans, ensure quality in manufacturing, and support regulatory filings for innovative medicines.
Role type
Principal Statistician (Pharmaceutical Manufacturing & Quality)
Builds
Statistically optimized non-clinical development plans, quality assurance strategies, and regulatory filing support for drug manufacturing.
Domain
Pharmaceutical industry, drug development, cGMP-regulated manufacturing, and quality assurance.
Deliverable
production ML models
Required skills
Bayesian statistics, R, Python, JMP, advanced statistical analysis, data manipulation, simulation, project management, team leadership, regulatory compliance knowledge (FDA/EMEA/ICH), process improvement, yield optimization.
Preferred skills
Experience in commercial manufacturing, advanced analytics and AI techniques, industry forum representation, scientific computing tool development.
Responsibilities
Apply statistical techniques to facilitate decision-making and improve business operations; Contribute to strategic planning for non-clinical development plans and regulatory filings; Provide leadership and SME support for complex data analysis including stability analysis and yield improvement; Collaborate globally to identify improvements in yield, robustness, and quality; Manage multiple studies to ensure consistency and adherence to standards; Drive innovation in advanced analytics and AI for process and quality applications; Mentor junior staff and provide statistical training; Maintain expertise in computing tools (R, Python, JMP) and represent the company at industry forums.
Seniority
Principal, hands-on IC with leadership and mentorship responsibilities.