Biostatistician II

Thermo Fisher Scientific

Wilmington, North Carolina

Date Posted January 23, 2023
Industry Clinical Research
Specialty Not Specified
Job Status Not Specified
Salary Not Specified

Description:

Company Name: PPD Development, L.P.
Position Title: Biostatistician II
Location: 929 North Front Street, Wilmington, NC 28401

Summary of Duties: Function independently as a lead statistician with minimal oversight to deliver the project statistician tasks/responsibilities, including analysis database creation, statistical analyses, and creation of formatted statistical analysis tables and summaries. Provide mentorship to junior team members. Ensure compliance with the activities outlined in the department's SOPs. Follow departmental procedures for statistical analyses and programming work. Lead a project team. Conduct team meetings, maintain project timelines, assess resources needed, provide resources, and prepare the budget. Ensure that SOPs are being followed and that appropriate project documentation is ongoing. Interact with the sponsor on all aspects of the project. Coordinate with programmers and data management personnel as to database maintenance, updating, and documentation. Provide guidance for database structures for analysis. Provide sample size calculations and review protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provide randomization schemes and appropriate documentation. Develop statistical analysis plan, including analysis database and table and listing specifications, and guide others on the team in its implementation. Program/validate statistical tables with an emphasis on efficacy endpoints. Provide proper documentation and oversee the work of others who assist in programming/validating. Review reports and other documents and manuscripts. Contribute to the statistical methods section and verify for completeness and consistency for report. Monitor project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope. Provide general infrastructure support to the department. Duties may be performed remotely.

Qualifications: PhD in Statistics, Biostatistics, Biological and Biomedical Science, Mathematics, or related field, and six (6) months of experience as a Teaching Assistant, Postdoctoral Fellow, Biostatistician, or related role. Employer will also accept a Master’s degree in Statistics, Biostatistics, Biological and Biomedical Science, Mathematics, or related field, and two (2) years of experience as a Teaching Assistant, Postdoctoral Fellow, Biostatistician, or related role. If qualifying with a PhD, six (6) months of 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 experiments in introducing conditions designed to affect an outcome of interest. If qualifying with a Master’s degree, employer will accept two (2) years of experience with the aforementioned skills.