The Senior Manager, Biostatistics to Director, Biostatistics is responsible for providing statistical support to drug development programs.
Essential Functions of the Job (Key responsibilities)
• Interact with members of the multidisciplinary project teams to establish project timelines.
• Provide statistical input to study protocols.
• Write statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Provide guidance and supervision to programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
• Interpret study results and provide review of statistical summary reports of study results for accuracy.
• Assist in writing relevant sections of the clinical study report.
• Participate and contribute to authoring of Clinical Development Plan.
• Participate in pre-IND and NDA activities.
• Participate in the development and enforcement of SOPs and guidelines.
• Other duties, as required.