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.