About this role
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of Thermo Fisher Scientific, you’ll support a global biopharmaceutical partner advancing immunology through co-creation—bringing scientific expertise and patient perspectives together to pursue what once seemed out of reach. You’ll bring statistical insight to clinical research for people living with rare and serious diseases, helping a collaborative team advance new possibilities for patients.
What you’ll do
- Ensure work follows departmental standard operating procedures (SOPs) and statistical analysis and programming procedures. Recommend updates when needed.
- Lead statistical work across multiple complex projects, independently serving as project lead or lead statistician. Provide senior review and guide team members.
- Interact with sponsors on project matters and present to sponsors and regulatory agencies as needed.
- Review sample size calculations, protocols, and randomization documentation for completeness, appropriate clinical design, and sound statistical methods. Contribute statistical content to protocols.
- Write or review statistical analysis plans, define appropriate methods, guide team members in implementation, and review analyses of key efficacy endpoints.
- Review analysis database specifications, oversee database development, and ensure databases are complete for programming. Coordinate with programmers and data management on database maintenance, updates, and documentation. Oversee creation of table and listing specifications.
- Prepare reports, manuscripts, and other study documents. Contribute statistical methods sections for Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and related documents.
- Monitor project budgets against scope. Communicate potential scope changes to management and, after review with management, discuss scope and budget changes with sponsors.
- Mentor department members through project guidance, statistical advice, employee development, performance planning, and resource planning.
- Provide input on hiring recommendations, department policies, and resourcing needs.
- Represent the department to other divisions and support bidding and business development activities, including advising on bids and timelines.