The Senior Biostatistician to Director, Biostatistics is responsible for providing statistical support for drug development programs in all phases of development.
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.