Work Schedule

Environmental Conditions

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.

Expertise in statistical analysis, clinical study design, sample size calculation, protocol development, randomization methods, analysis plan writing, database specification, data management collaboration, report preparation, and regulatory presentation.

Key Responsibilities

• leading statistical analyses
• reviewing protocols
• mentoring team members

Job Details

• Category: Data and Analytics
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — North Carolina, United States
• Salary: USD 110,000 – 145,000 / year
• Languages: English

About Thermo Fisher Scientific

A global healthcare and life sciences company providing clinical research and biostatistics services. — Industry: Healthcare