Biostatistician II
PharmaClinical Researchbiostatisticsemainform
Job description
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Biostatistician II Summarized Purpose: Functions 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. Provides mentorship to junior team members. Essential Functions and Other Job Information: Essential Functions • Ensures compliance with the activities outlined in the department's SOPs. Follows departmental 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 as to 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 guide others on the team in its implementation. • Programs/validates statistical tables with an emphasis on efficacy endpoints. Provides proper documentation and oversee the work of others who assist in programming/validating. • Reviews reports and other documents and manuscripts. Contributes to the statistical methods section and verify 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 Qualifications: Education and Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’). Master's degree in statistics, biostatistics, mathematics or related field
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