About This Role
This statistician role is an early opportunity to gain extensive industry experience, particularly for someone with leadership skills. The core of the job involves defining appropriate statistical analysis methods and procedures, writing and reviewing analysis plans, and guiding team members in their implementation.
Responsibilities
- Function independently as a project lead or lead statistician to deliver project tasks and responsibilities
- Perform project management functions relating to the administrative and scientific activities of specific project work and team members
- Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians
- Support the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies
- Ensure compliance with the activities outlined in the department's Working Practice Documents and contribute changes as needed
- Follow departmental procedures for statistical analyses and programming work
- Work independently as a project lead or as lead statistician to deliver on lead tasks and responsibilities across large and complex projects
- Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed
- Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis
- Contribute to writing appropriate protocol sections
- Provide randomization schemes and appropriate documentation
- Write and review analysis plans and guide others on the team in its implementation
- Define appropriate methods and procedures for statistical analysis
- Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming
- Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation
- Perform statistical analysis for key efficacy endpoints
- Prepare reports, manuscripts, and other documents
- Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents
- Monitor project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope
- Communicate with sponsors concerning project work scope and budgetary changes after reviewing with management
- Mentor members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning
