Senior Statistician II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

• •Ensures compliance with the activities outlined in the department's SOPs and
• contribute changes as needed. Follows departmental procedures for statistical
• analyses and programming work.
• •Work independently as a project lead or as lead statistician to deliver on lead
• tasks/responsibilities across challenging projects; provides senior review on
• projects. Leads team members across multiple complex projects. Interacts with
• the sponsor on all aspects of the project and present to sponsor and regulatory
• agencies as needed.
• •Reviews sample size calculations and protocols for completeness,
• appropriateness of clinical design, and sound statistical analysis. Contributes to
• writing appropriate protocol sections. Reviews randomization related
• documentation.
• •Writes / reviews analysis plans and guide others on the team in its
• implementation. Defines appropriate methods and procedures for statistical
• analysis. Reviews statistical analysis for key efficacy endpoints.
• •Reviews specifications for analysis database, oversees its development, and
• assures completeness for use in all programming. Oversees collaboration with
• programmers and data management personnel as to database maintenance,
• updating, and documentation. Supervises creation of table and listing
• specifications.
• •Prepares reports, manuscripts, and other documents. Contributes statistical
• methods section for Integrated Clinical and Statistical Report, Integrated
• Summaries of Safety, Integrated Summaries of Efficacy, and other documents.
• •Monitors project budget as it relates to project work scope and communicate
• proactively with management concerning potential changes in work scope.
• Communicates with sponsors concerning project work scope and budgetary
• changes after reviewing with management.
• •Mentors members of the department by providing project guidance and
• statistical advice and by promoting employee development, contributing to
• performance planning, and providing resource planning.
• •Provides input on hiring recommendations, department policies, and resourcing
• requirements.
• •Acts as representative of the department to other divisions. Assists in bidding
• and business development activities. Consults with business development with
• respect to bids and timelines.