Department: MED-Preventive Medicine Salary/Grade: EXS/8
Partners with study teams to design, develop, implement and maintain data management and analysis for clinical trials and observational studies. This includes database administration, data consolidation, data analysis and reporting. Utilizes software to generate metrics and statistical analysis. Collaborates with multiple cross functional study teams and may additional function as project coordinator. Contributes to the writing of clinical study protocols, conducting clinical activities, navigating regulatory approvals, and collaborating on publications to disseminate clinical results within national and international settings.
Manages and plans for data/analysis requests and projects.
Provides consultation to customers on appropriate data management, methodological issues and statistical analyses.
Reviews reports before presentation to ensure quality and accuracy.
Develops and maintains documentation of process for quality assurance and reporting methodology
Defines, develops and communicates new standards and best practices.
Contributes to development of clinical plans, protocols, and standard operating procedures (SOP)
Develops queries and quality metrics.
Prepare data tables for preliminary, interim, and final analysis
Interprets results using a variety of techniques, ranging from simple data aggregation via statistical analysis to complex statistical analysis.
Determines data structure for local datasets.
Develops and documents standards for data quality and regulatory compliance pertaining to reporting.
Ensures quality and compliance by reviewing reports
Maintain documentation of statistical methods and programming code
Collaborate on or lead dissemination of results through publications and presentations
Manages projects ensuring timelines and deliverables are met and meet expectations.
Performs other duties as assigned.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience.
4 years data analysis/report writing or similar experience required.
Infrastructure (extends across applications)
Microsoft Office (Word, Excel, Powerpoint, Access, Outlook)
Programming Languages and Frameworks
21 CFR Part 11
Other: Good Clinical Practice
Database design/ data structure
Other: Statistical Analysis
Collaboration and teamwork
Successful completion of a master’s degree in statistics, epidemiology, or public health with emphasis on analytical skills from an accredited college or university; OR appropriate combination of education and experience.
4 years data analysis/report writing and project management or similar experience required.
Project management training or experience
2 or more years experience working internationally or working with International teams
Preferred Competencies: (Skills, knowledge, and abilities)
Excellent written and oral communications skills
Strong organizational and interpersonal skills with ability to multi-task and manage multiple projects in parallel.
Prior experience with electronic medical records, eCRFs and electronic clinical trials management systems
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 38453
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.