Job Description

• Ensures compliance with the activities outlined in the department's SOPs.

Follows departmental procedures for statistical analyses and programming work.

• Leads a project team. Conducts team meetings, maintains project timelines,

assesses resources needed, provides resources, and prepares the budget.

Ensures that SOPs are being followed and that appropriate project

documentation is ongoing.

• Interacts with the sponsor on all aspects of the project.

• Coordinates with programmers and data management personnel as to database

maintenance, updating and documentation. Provides guidance for database

structures for analysis.

• Provides sample size calculations and reviews protocols for completeness,

appropriateness of clinical design, and sound statistical analysis.

• Provides randomization schemes and appropriate documentation.

• Develops statistical analysis plan, including analysis database and table and

listing specifications, and guide others on the team in its implementation.

• Programs/validates statistical tables with an emphasis on efficacy endpoints.

Provides proper documentation and oversee the work of others who assist in

programming/validating.

• Reviews reports and other documents and manuscripts. Contributes to the

statistical methods section and verify for completeness and consistency for

report.

• Monitors project budget as it relates to project work scope and communicates

proactively with management concerning potential changes in work scope.

• Provides general infrastructure support to the department. Examples could

include presentation/ teaching at department, contributing to other general

department documents or policies, assisting with newsletters, helping in

department libraries, or training of new hires.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.