Principal Scientist - CMC Statistician
Tasks
- Deliver statistical expertise for experimental design and data analysis
- Design and analyze complex studies for health authorities
- Develop statistical methodologies for internal working groups
- Perform statistical analyses using R SAS Python JMP SIMCA Modde
- Prepare statistical reports, memos, and presentations
- Promote statistical thinking through training
- Provide statistical support for process development
- Serve as CMC statistics contact between functions
- Train customers on validated statistical methodologies
- Write statistical study reports for regulatory compliance
Perks/Benefits
Skills/Tech-stack
Analytical method transfer | Analytical method validation | By Design | CMC | Chemical Manufacturing | Chemical Manufacturing Control | Comparability studies | Control Charts | Data Analysis | Design of Experiments | Dossier Writing | EMA | Experimental Design | Exploratory Data Analysis | FDA | GMP | ICH | JMP | Linear modeling | Manufacturing control | Method transfer | Method validation | Modde | Multivariate analysis | Nonlinear modeling | Pharmaceutical Development | Process Development | Python | Quality by Design | R | RShiny | Regulatory Dossier Writing | Regulatory dossier | SAS | SIMCA | Specification Limits | Stability Modeling | Statistical modeling | Statistics
Education
Roles
CMC Statistician | Principal | Principal Scientist | Scientist | Statistician
Regions
Countries
States
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