Biostatistician II

November 6

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Thermo Fisher Scientific

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Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics

10,000+

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.

Requirements

• At least 3 years industry experience in a Biopharma or Biotech • Education: A minimum of a Master’s Degree in Statistics • Lead experience: Experience leading a project team - Conducts team meetings, maintains project timelines, assesses resources needed, provides resources, and prepares the budget. • Coordinates with programmers and data management personnel. • 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, 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.