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 issues related to biostatistics

Qualification: MSc., PhD in Biostatistics

Experience: 10-15 years' experience in a Pharma / CRO