Desired Experience
- Experience of biostatistics in regulated markets
- Interacted with regulatory agencies (FDA/EMA/PMDA)
- Experience of biosimilar product development
- Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis
- Knowledge of using relevant software including PASS, SAS, SPSS, R
Job Description
- Prepare scientifically sound statistical design for clinical trials
- Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA)
- Perform meta-analysis and calculate sample size
- Prepare statistical justifications for agency interactions (FDA/EMA/PMDA)
- Review and provide inputs to statistical sections of clinical trial protocol
- Plan and perform blinded sample size re-estimation and interim analysis
- Review and provide inputs to statistical analysis plan and CRF
- Review tables, listings, figures and clinical study reports
- Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics
- Respond to agency queries on issues related to biostatistics
Qualification: MSc., PhD in Biostatistics
Experience: 10-15 years experience in a Pharma / CRO
