Research Scientist – Program Lead & Data Analyst

University of Colorado•Aurora, CO

22h•$85,000 - $95,000•Remote

About The Position

The Department of Orthopedics, Hand Division has an opening for a full-time Research Scientist. This position is responsible for implementing, operationalizing, and coordinating clinical research studies/trials as well as Data Analyst duties. The Research Scientist will serve as the Program Lead & Data Analyst for clinical studies. This position will assist faculty with all aspects of administrative activities related to the submission of Institutional Review Board (IRB) protocols to the Colorado Multiple Institutional Review Board (COMIRB), Western IRB (WIRB), and other regulatory agencies. This includes protocol development, writing consent forms, adverse event reporting, monitoring FDA-IDE trials, and managing continuing reviews of protocols. The Research Scientist will ensure compliance with all internal and external policies and procedures that govern the department’s human subject research by navigating each institution’s applicable policies (University of Colorado, Children’s Hospital Colorado, UCHealth, & VA Eastern Colorado Health Care System). The Research Scientist will interact with patients during study visits and ensure completion of all necessary documentation, as well as facilitating study-related billing. This position will also assist in the development and maintenance of a record keeping system of protocols for COMIRB and other regulatory agency activities. The analyst will provide biostatistical analysis, data management and consulting for Veterans Affairs and Orthopedic researchers at the University of Colorado Denver, Anschutz Campus as well as collaborate with investigators on database design and biostatistical aspects of the research process, including the design and development of surveys, structuring data collection systems, data reduction and analysis, and assistance with preparation of abstracts, talks, and manuscripts.

Requirements

MS in Biostatistics/Statistics, Master of Public Health (MPH), or MS in Epidemiology with Biostatistical emphasis and/or Epidemiology concentration or similar
Experience with study design and analysis techniques, including univariate and multivariate analyses, particularly regression analyses (linear, logistic, multinomial, Poisson).
Experience with data management, production of ongoing data reporting and graphics/table creation
Experience working with large datasets, and knowledge of entity relationship diagrams and relational databases.
Excellent knowledge regarding IRB policies and procedures
Excellent knowledge regarding Sponsor and FDA regulatory requirements
Proficiency in a statistical software package, such as SAS, SPSS, or STATA
Firm understanding of the principles and practices of clinical research
Must have strong personal direction and motivation: able to perform duties autonomously as well as under direct supervision
Great attention to detail
Ability to work in a confidential and professional manner
Excellent communication skills, both written and verbal
Ability to problem solve and multi-task
Excellent computer skills

Nice To Haves

Minimum 5-year research or academic clinical experience
Experience with SPSS, SAS, Stata and REDCap
Database creation and analysis, familiarity with relational data such as with Microsoft Access or SQL Server Management Studio
Familiarity with NCSS PASS (sample size calculations) or GPower, Epic electronic health record

Responsibilities

Monitor and coordinate ongoing research projects and maintain clinical study database records
Provide study updates to Principal Investigators through bi-monthly meetings
Track upcoming patient study visits and interact with patients during visits
Oversee and support research staff (medical students, undergraduate students, residents, and hand fellows), serving as primary contact for data collection troubleshooting
Conduct literature searches and reviews
Design and implement research protocols for consistent data collection and management
Create and maintain research study databases and surveys in collaboration with study teams
Ensure research data has gone through proper data checking prior to use in analyses
Pull data from national and local databases, manipulate, clean, score measures, and prepare data for analyses and reporting
Perform basic & intermediate statistical analysis independently and advanced statistical analyses in collaboration with senior statistician(s)
Participate in data analysis and prepare study reports, manuscripts, meeting materials, and grant submissions
Develop, revise and update research documents including all COMIRB & WIRB regulatory submissions
Present research at scientific meetings and participate in manuscript preparation
Work independently and collaborate with co-investigators and other institutions, serving as liaison between collaborators and the PI
Participate in Musculoskeletal Research Center weekly meetings and undertake sub-committee responsibilities