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How to Apply

A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

This position supports statistical activities for several grants within the Department of Biostatistics’ Statistical Analysis of Biomedical and Educational Research (SABER) unit, which is the Data Coordinating Center for several multi-center clinical trials and observational studies. SABER responsibilities include collaborating with investigators on the design and analysis of clinical trials and observational studies, under the supervision of faculty biostatisticians. 

Responsibilities*

With guidance and oversight of faculty biostatisticians,

  • Collaborate on study design from a wide variety of clinical trials and observational studies perspectives, including sample size estimation and development of randomization schemes
  • Conduct data analyses in SAS or R, which includes
    • Prepare statistical analysis plans, including table shells
    • Write analysis programs
    • Validate analysis programs
    • Prepare analysis reports for submission of abstracts and papers to scientific journals
    • Prepare reports for DSMB, FDA, or steering committee review
  • Review / prepare  statistical considerations sections (including definition of subject population, endpoints, sample size) of study protocols
  • Collaborate with the SABER cross-functional team on the design, conduct and reporting of clinical studies per GCP; tasks may include review of CRFs, edit checks, standard reporting programs for internal team use
  • Implement methods to ensure the quality of study data, including participation in development of and implementation of standard operating procedures

 

Required Qualifications*

  • Master’s in statistics, biostatistics, or related field  
  • At least 1 year of experience full-time experience working with clinical data, preferred
  • Experience with data cleaning and review and implementing database quality assurance standards, knowledge of databases, such as Oracle and ACCESS
  • Knowledge and experience with SAS, including knowledge of data step processing and macro languages
  • Experience in the analysis and reporting of clinical trials or epidemiologic studies
  • Understanding of ICH, GCP and FDA regulations and guidelines with regard to the conduct of human subject research
  • Good communication skills
  • Ability to work effectively on teams, and collaborate with SABER senior statisticians and colleagues
  • Able to multi-task and manage competing priorities effectively 

Underfill Statement

This position is posted at the Intermediate level but could be filled at the Associate or Senior level depending on education and experience.  

Background Screening

The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks will be performed in compliance with the Fair Credit Reporting Act.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.