Senior Statistician II

NCBioImpact; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

NCBioImpact in North Carolina is seeking a senior statistician to lead complex clinical projects, design analyses, and provide expert review across studies. You will mentor team members, coordinate with sponsors and regulatory bodies, oversee analysis plans and databases, and monitor project budgets while contributing to strategic planning.

This role requires strong collaboration with cross-functional teams, excellent written and verbal communication, and the ability to present findings to

Responsibilities

• Ensures compliance with SOPs and statistical analyses and programming work.
• Work independently as project lead or lead statistician across challenging projects; provides senior review and mentors team.
• Reviews sample size calculations and protocols for clinical design and analysis; contributes to writing protocol sections.
• Writes/reviews analysis plans and guides others on implementation; defines methods for statistical analysis.
• Oversees analysis databases development and collaboration with programmers and data management; supervises table/listing specs.
• Prepares reports/manuscripts for Integrated Clinical and Statistical Reports and summaries.
• Mentions project budget and communicates with management on scope and budget changes; liaises with sponsors.
• Mentors department members, contributes to performance planning and resource planning; provides input on hiring and policies.
• Acts as department representative to other divisions; assists in bidding and business development; consults with business development on bids/timelines.

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.