Statistician (ROCGJP00027134)
Tasks & Responsibilities:
- Support synthetic molecule development pipeline work, e.g. process characterization, process validation, process transfer, assay validation, assay transfer, shelf life study.
- Support synthetic molecule commercial manufacturing, e.g. process monitoring, process troubleshooting and optimization.
- Collaborate with other statisticians on method development and improvement.
Your background:
- Master’s or Ph.D. in Statistics, Biostatistics, Mathematics, Pharmaceutical Sciences, or a closely related field
- Statistical Analysis: Advanced proficiency in statistical methods and software (e.g., R and JMP) for the design of experiments and data analysis (e.g. linear mixed models)
- Design of Experiments (DOE): Extensive experience in designing experiments, e.g., in the context of process characterization, optimization, and process validation
- Data Interpretation: Expertise in analyzing and interpreting complex datasets to derive meaningful insights and support decision-making
- Consulting and Teaching Skills: Ability to effectively communicate complex statistical concepts to professionals without statistical background. Ability to ask the right questions and to promote statistical thinking. Ability to translate from business problems to statistical framework
Nice to Have:
- Pharmaceutical Technical Development: Deep understanding of pharmaceutical sciences with a focus on synthetic molecule development
- Regulatory Compliance: Strong familiarity with regulatory guidelines and standards in the pharmaceutical industry (e.g., FDA, EMA) to ensure compliance
- Problem-Solving: Strong analytical and problem-solving skills to address challenges in experimental design and data analysis
- Project Management: Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards
- Ability to keep abreast of new developments in statistics, data science, and drug development
À propos de l'entreprise
