– 6 month potentially renewable contract
Acts as lead statistician on projects of moderate to large size and complexity; supports lead statistician on very large, complex studies. May have staff management and/or project management responsibilities. Writes statistical reports. Aids in the development of protocols.
• Becomes familiar with the activities outlined in the department's Working Practice Documents and contributes changes as needed. Learns and follows departmental procedures for statistical analyses and programming work.
• Serves as a lead statistician on moderate and large projects.
• 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.
• Coordinates with programmers and data management personnel as to database maintenance, updating and documentation. Provides guidance for database structures for analysis.
• Creates or provides specifications for analysis databases based on Data
• 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 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.
• Prepares and reviews reports, including interim reports, final Integrated Clinical and Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other documents and manuscripts. Contributes to the statistical
methods section and verify for completeness and consistency for report.
• Interacts with the sponsor on all aspects of the project.
• Understands project budget as it relates to project work scope and communicate proactively with management concerning potential changes in work scope.
• Provides general infrastructure support to the Biostatistics Department.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
MS/MA degree in statistics, biostatistics, mathematics or related field and two years experience preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to
2+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
• Strong SAS® programming skills and understanding of database structures