Clinical Research

• Plan, analyze, and summarize results of individual clinical studies or groups of studies
• Coordinate development and review of regulatory submissions
• Program and/or review statistical tables, listings, figures, and analysis datasets for clinical trials
• Work with project team personnel and vendors to meet project deliverables and timelines for statistical data analysis and reporting
• Provide sample size calculations and review protocols for completeness
• Provide randomization schemes and appropriate documentation per SOPs
• Monitor project budgets and support project forecasting efforts
• Serve as project manager when a clinical development PM does not exist
• Contribute to departmental initiatives
• Serve as subject matter expert for Biostatistics and Programming teams
• Provide statistical advice regarding study design, endpoints, sample size requirements, and methodology
• Author statistical analysis plans and study specifications
• Serve as primary statistical contact for the study/project team
• Use regulatory agency requirements and guidance documents to support clinical development programs
• Use literature knowledge to provide data analysis and presentation methods for publications and presentations
• Lead study team meetings as needed
• Perform other duties as assigned

Clinical Research jobs in India

Biostatistician II