Sr Biostatistician

Job Description

• Ensures compliance with the activities outlined in the department's Working Practice Documents and contributes 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 large and complex projects. Interacts with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. • Provides sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contributes to writing appropriate protocol sections. Provides randomization schemes and appropriate documentation. • Writes / reviews analysis plans and guide others on the team in its implementation. Defines appropriate methods and procedures for statistical analysis. • Provides specifications for analysis database, oversee its development, and assures completeness for use in all programming. Coordinates with programmers and data management personnel as to database maintenance, updating, and documentation. Performs statistical analysis for key efficacy endpoints.• 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, completing performance planning, and providing resource planning. • Provides general infrastructure support to the Department (presents / teaches at the department meetings, contributes to other general department documents or policies, assists with newsletter, helps in department libraries, or trains new hires). • Acts as the representative of the department to other divisions. Assists in bidding and business development activities. Consults with business development with respect to bids and timelines.