Biostatistician II

• 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.