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Company Name: PPD Development, L.P.

Position Title: Sr. Biostatistician II

Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Function independently as a project lead or lead statistician to deliver the project tasks/responsibilities. Perform project management functions relating to the administrative and scientific activities of specific project work and team members. Oversee statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. Support the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies. Ensure compliance with the activities outlined in the department's Working Practice Documents and contribute changes as needed. Follow 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 large and complex projects. Interact with the sponsor on all aspects of the project and present to sponsor and regulatory agencies as needed. Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Contribute to writing appropriate protocol sections. Provide randomization schemes and appropriate documentation. Write / review analysis plans and guide others on the team in its implementation. Define appropriate methods and procedures for statistical analysis. Provide specifications for analysis database, oversee its development, and assure completeness for use in all programming. Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation. Perform statistical analysis for key efficacy endpoints. Prepare reports, manuscripts, and other documents. Contribute statistical methods section for Integrated Clinical and Statistical Report, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents. Monitor project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Communicate with sponsors concerning project work scope and budgetary changes after reviewing with management. Mentor members of the department by providing project guidance and statistical advice and by promoting employee development, completing performance planning, and providing resource planning. Provide general infrastructure support to the Department (present / teach at the department meetings, contribute to other general department documents or policies, assist with newsletter, help in department libraries, or train new hires). Act as the representative of the department to other divisions. Assist in bidding and business development activities. Consult with business development with respect to bids and timelines. Remote work available.

Qualifications: Master’s degree in Biostatistics, Statistical Science, Statistics, or related field and four (4) years of experience as Biostatistician, Statistician, Statistical Research Associate, Teaching Assistant or related role. Must have four (4) years’ experience with: Statistical programming language, SAS or R; Statistical principles and methodology; Principles of statistical inference, including hypothesis testing and deriving estimates; Parametric models and techniques; Non-parametric modeling techniques; Principles of sample size calculations needed for comparing two samples; and Principles of design of experiments in introducing conditions designed to affect an outcome of interest. Three (3) years’ experience with: Phase II-IV clinical trial data analysis experience. Two (2) years’ experience with: Project management.

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