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 aroun...