Senior Manager, Principal Statistician
Core
Provide statistical analysis, direction, and training to Global Product development & Supply (GPS) clients worldwide to ensure batch compliance and prevent product issues.
Role type
Senior Manager, Principal Statistician (Biopharma Manufacturing)
Builds
Process robustness, method lifecycle qualifications, and compliance for drug manufacturing and packaging.
Domain
Biopharmaceutical manufacturing and supply chain
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design of Experiments (DOE), regression modeling, variance component analysis, multivariate analysis, process capability, control charts, statistical package proficiency (JMP, SAS, R), study design, data interpretation, training non-statisticians
Preferred skills
CMC statistics background, FDA/EMEA cGMP knowledge, ICH/USP regulatory guidelines, project management in dynamic environments
Technologies
JMP, SAS, R
Responsibilities
Determine sound statistical techniques for GPS stakeholders; collaborate with process analytical teams and subject matter experts; support analytical teams in QC and Analytical Sciences for method lifecycle and reference standard qualification; develop and select statistical methods for study design and analysis to assure batch compliance; conduct thorough data analysis and provide recommendations; contribute to improvement and standardization of statistical processes; further statistical awareness and competency of other personnel.
Seniority
Senior Manager, hands-on IC with mentorship responsibilities
