Senior Statistician II

Thermo Fisher Scientific•Morrisville, NC
•Onsite

About The Position

The Senior Statistician II independently leads statistical work across challenging and complex projects, provides senior-level project review, and works with sponsors, regulatory agencies, programmers, data management personnel, and other divisions. The role ensures adherence to departmental SOPs and procedures, contributes to protocol and statistical documentation, oversees statistical analysis and database-related work, monitors project scope and budget, and mentors department members. It also supports hiring, resource planning, bidding, and business development activities.

Responsibilities

  • Ensure compliance with departmental SOPs, contribute changes as needed, and follow departmental procedures for statistical analyses and programming work.
  • Lead statistical tasks and responsibilities across challenging projects, provide senior project review, and 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, appropriateness of clinical design, and sound statistical analysis; contribute to relevant protocol sections and review randomization documentation.
  • Write and review analysis plans, guide their implementation, define statistical methods and procedures, and review analyses for key efficacy endpoints.
  • Review analysis database specifications, oversee database development and completeness, coordinate database maintenance and documentation with programmers and data management personnel, and supervise table and listing specifications.
  • Prepare reports, manuscripts, and other documents; contribute statistical methods sections for integrated clinical and statistical reports and integrated safety and efficacy summaries.
  • Monitor project budgets against work scope and communicate potential scope changes to management; discuss scope and budget changes with sponsors after management review.
  • Mentor department members through project guidance, statistical advice, employee development, performance planning, and resource planning.
  • Provide input on hiring recommendations, department policies, and resourcing requirements.
  • Represent the department to other divisions and assist with bidding and business development, including advising on bids and timelines.
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