DGM/GM - Biostatistician

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 iss...