Clinical Statistical Design Specialist

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 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