AD Biostatistics at On Assignment, Inc./Oxford Global Resources in Denver, Colorado

Posted in Other 12 days ago.





Job Description:

Summary:

Provides statistical support to development and clinical research projects; interacts with research personnel to ascertain needs and develops appropriate design and statistical solutions. Writes statistical analysis plans (SAPs) and statistical reports for use by internal and external customers.


Project Details:


  • Interact with product developers and clinical investigators to design clinical trials with appropriate statistical methods and adequate sample size for statistical justification of clinical utility claims.

  • Write data analysis plans as needed to capture design elements and statistical methodology.

  • Perform data analysis and prepare statistical reports of results.

  • Perform Quality Control (QC) for statistical analyses by other biostatisticians to ensure analysis quality.

  • Conduct randomization and blinding of samples.

  • Develop data entry spreadsheets as needed.

  • Evaluate databases and statistical analysis programs and interact with computer groups to determine hardware/software compatibility.

  • Maintain expertise in state-of-the-art data manipulation and statistical analyses.

  • Manage technical aspects of project(s), as assigned.

  • Monitor work to ensure quality, and continuously promotes Quality First Time.



Job Experience:

  • Knowledge of FDA guidelines and the required statistical basis for sensitivity, specificity, agreement rates, and FDA clearance and approval.

  • Strong ability to collaborate across departments and interact with various levels in the organization.

  • High attention to detail with skill in producing organized reports.

  • Ability to write statistical code and documentation.

  • Ability to work in a team-focused environment is essential, as all statistical analyses under design control require both lead statistical analysis and quality control (QC), each conducted by different individuals who must coordinate activities.

  • Master's degree in Statistics or a related field

  • PhD degree in Statistics or a related field

  • Masters plus 3 years statistical analysis in a healthcare environment or PhD plus significant experience in analysis and reporting using statistical software



Oxford is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefits@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
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