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 | dashboards & analysis
Required skills
Bayesian statistics, R, Python, JMP, project management, team leadership, regulatory compliance knowledge (FDA/EMEA/ICH), advanced statistical analysis, data manipulation, simulation, mentoring.
Preferred skills
Experience in commercial manufacturing, knowledge of advanced analytics and AI techniques, industry forum participation.
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; provide leadership and SME support for complex data analysis requests; collaborate globally to identify yield and quality improvements; manage multiple studies for consistency and adherence to standards; drive innovation in advanced analytics and AI; act as a strategic partner in the drug manufacturing process; communicate statistical work to stakeholders; 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 leadership and mentorship responsibilities.