Senior Statistician II

Thermo Fisher Scientific•Morrisville, NC

6d•Onsite

About The Position

The Senior Statistician II independently leads statistical work on challenging and complex projects, serves as a lead statistician, and provides senior review. The role works with sponsors and regulatory agencies, guides team members, and contributes to statistical planning, analysis, programming, reporting, project budgeting, staff development, hiring, and business development. The position follows departmental procedures and ensures compliance with applicable standard operating procedures.

Responsibilities

Ensure compliance with departmental SOPs and contribute changes as needed.
Follow departmental procedures for statistical analyses and programming work.
Independently lead projects or serve as lead statistician, delivering lead tasks and providing senior review across challenging projects.
Lead team members across multiple complex projects.
Interact with sponsors on project matters and present to sponsors and regulatory agencies as needed.
Review sample size calculations and protocols for completeness, appropriate clinical design, and sound statistical analysis; contribute to appropriate protocol sections.
Review randomization-related documentation.
Write and review analysis plans, guide team members in implementation, define appropriate statistical methods and procedures, and review statistical analyses for key efficacy endpoints.
Review analysis-database specifications, oversee database development, and ensure completeness for programming; collaborate with programming and data management personnel on database maintenance, updating, and documentation.
Supervise creation of table and listing specifications.
Prepare reports, manuscripts, and other documents; contribute statistical methods sections for integrated clinical and statistical reports, integrated summaries of safety and efficacy, and other documents.
Monitor project budgets in relation to project scope and communicate potential scope changes to management; discuss scope and budget changes with sponsors after management review.
Mentor department members by providing project guidance and statistical advice, promoting employee development, contributing to performance planning, and providing resource planning.
Provide input on hiring recommendations, department policies, and resourcing requirements.
Represent the department to other divisions.
Assist with bidding and business development activities and consult with business development on bids and timelines.