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 infrastr

📌 Biostatistician II (España)
🏢 Thermo Fisher Scientific
📍 España