Biostatistician II

Job Description

• 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.