Scientist II, Biostatistics

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.