Highlights
Reviews sample size calculations and protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Communicates with sponsors concerning project work scope and budgetary.
Numbers & Facts
| Location | Morrisville, NC |
| Industry | All |
| Company Size | 10,000 employees or more |
| Website | https://corporate.thermofisher.com/en/home.html |
Description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
About Company
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.
All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.
If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.
Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.