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Environmental Conditions

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Job Description



Company Name: PPD Development, L.P.


Position Title: Biostatistician II


Location: 929 North Front Street, Wilmington, NC 28401


Summary of Duties: Ensures compliance with the activities outlined in the department's SOPs. Follows department procedures for statistical analyses and programming work. Leads a project team. Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. Ensures that SOPs are being followed and that appropriate project documentation is ongoing. Interacts with the sponsor on all aspects of the project. Coordinates with programmers and data management personnel for database maintenance, updating, and documentation. Provides guidance for database structures for analysis. Provides sample size calculations and reviews protocols for completeness, appropriateness of clinical design, and sound statistical analysis. Provides randomization schemes and appropriate documentation. Develops statistical analysis plan, including analysis database and table and listing specifications, and guiding others during implementation. Programs and validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversees the work of others who assist in programming and validating. Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verifies for completeness and consistency for report. Monitors project budget as it relates to project work scope and communicates proactively with management concerning potential changes in work scope. Provides general infrastructure support to the department. Examples could include presentation/teaching at department, contributing to other general department documents or policies, assisting with newsletters, helping in department libraries, or training of new hires. (Remote work available.)


Qualifications: Master's degree in Statistics, Biostatistics, Mathematics, or related field and two (2) years of experience as a Biostatistician, Statistician, Statistical Programmer, or related role. Must have two (2) years 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; One (1) year of experience with: Phase II-IV clinical trial data analysis. Experience with 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.


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