Thermo Fisher

Senior Statistician II

Skills

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.