Senior Statistician II

Work Schedule

Environmental Conditions

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.