Senior Statistician II

Location: Remote, North Carolina, USA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

• 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.