Location: Wilmington, DE [On-Site] Employment Type: Direct Hire Job ID: 7246 Date Added: 02/20/2020 Thank you for applying. Someone will be contacting you shortly. Uploading Data... Creating Application... Finishing up... A new application was submitted. * Required field. 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.