About the role
Key Responsibilities:
- Design, develop, and analyze in vitro study experiments, ensuring statistical rigor and accuracy.
- Apply appropriate statistical models and methodologies for data interpretation.
- Work closely with scientists, biologists, and researchers to provide statistical guidance in study design and result evaluation.
- Utilize statistical software (e.g., SAS, R, JMP, or Python) to conduct data analysis, visualization, and reporting.
- Validate and verify data integrity, ensuring compliance with regulatory guidelines (FDA, ICH, GLP).
- Develop and review statistical analysis plans (SAPs), study protocols, and technical reports.
- Support regulatory submissions by preparing statistical documentation and reports.
- Stay updated with the latest statistical methods and best practices in in vitro research.
- Master’s or Ph.D. in Statistics, Biostatistics, Bioinformatics, or a related field.
- 2-7 years of experience in statistical analysis of in vitro studies, preferably in the pharmaceutical, biotechnology, or life sciences sector.
- Strong knowledge of experimental design, regression models, ANOVA, DOE, and multivariate analysis.
- Proficiency in statistical software (SAS, R, JMP, Python, or equivalent).
- Experience with data visualization, trend analysis, and predictive modeling.
- Understanding of regulatory requirements and compliance standards (FDA, ICH, GLP).
- Excellent communication skills to present findings to cross-functional teams.
- Strong problem-solving skills and attention to detail.
- Experience in bioassays, pharmacokinetics, biomarker analysis, or toxicology studies.
- Familiarity with machine learning and AI-based statistical modeling.
- Knowledge of clinical and preclinical statistical applications.