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, quality assurance.
Deliverable
production ML models | dashboards & analysis
Required skills
Bayesian statistics, R, Python, JMP, statistical process control, yield improvement analysis, regulatory compliance (FDA/EMEA/ICH), team leadership, strategic planning, data-driven decision support.
Preferred skills
Advanced analytics, AI techniques, process innovation, mentoring, industry forum representation.
Technologies
R, Python, JMP
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 adherence to standards in manufacturing and quality; Drive innovation in advanced analytics and AI for process and quality applications; Act as a strategic partner to the matrix team in drug manufacturing and quality assurance; Prepare statistical courses and mentor junior staff; Maintain expertise in computing tools and represent the company at industry forums.
Seniority
Principal, hands-on IC with strategic leadership and mentorship responsibilities.