Research Data Analyst I

Department Overview

The Infectious Disease Research Unit is based out of the OHSU-PSU School of Public Health specializes in evaluations of infectious disease, in individual patients and the population as a whole. The group’s experts are national leaders in two rare diseases that predominantly affect the lungs – nontuberculous mycobacterial, or NTM disease, and bronchiectasis. In addition to NTM disease and bronchiectasis, other areas of research include rheumatologic disease, drug safety and pharmacoepidemiology, and vaccines.

 

This position will participate in the IDRU Data Team, which is a small team within the group, working on projects including the design, documentation, testing, and implementation of research studies. The IDRU Data Team supports data-related aspects of projects within the group including the conduct of data/statistical procedures, as well as other collaborators in SPH and across OHSU.

 

Responsibilities of this clinical research data analyst position include:

• In conjunction with subject matter experts and under the direction of the IDRU’s lead clinical research data analyst, support research proposal and protocol development, research instruments, and other tools for data analyses.
• Participate in the IDRU’s Data Team, including working with SPH and external collaborators on research projects based on skill set. Implement the statistical analysis plan as recommended, participate in monthly meetings, and communicate with stakeholders as needed.
• Under guidance conduct data analyses on appropriate data samples or populations, utilize appropriate statistical methods, techniques, and computer applications, and develop recommendations based on research findings.
• Prepare reports, charts, tables and other data visualization aids to interpret and communicate data and analysis results.
• Participate in data entry, database management, statistical programming, and research analysis methods and interpretations.

The individual in this role will have strong person-skills, have a strong statistical background including familiarity with statistical software, be detail-oriented, and able to track multiple projects long-term. This position requires majority on-site work, with potential opportunity to work remotely. This position will be involved in manuscript review and represent the team at conferences.

Function/Duties of Position

• Supporting data management of both FDA-regulated and non-FDA-regulated clinical trial protocols and research projects, both within IDRU and across OHSU collaborators. These tasks include helping with the development of statistical analysis plans, database build and management, running data validations and querying data, interface with study Sponsors, help to manage IRB submissions and approvals, provide reports for IND submissions to the FDA, and data analyses and interpretation. 

• Participate in the IDRU’s Data Team work, including supporting study design, conducting data analyses, utilizing appropriate statistical methods, providing education, training, and to colleagues within the team, and communicate with stakeholders as needed. 

• Help manage study coordination work for several NTM-focused clinical trials, or research protocols, with a focus on data-specific tasks. Responsibilities may include unblinded staff tasks, such as monitoring data, preparing DMC reports, meeting with DMSB and communicating results with sites, interfacing with study Sponsor, and managing regulatory documentation. 

• Support new clinical trial start-up procedures by providing necessary regulatory documents to align with OHSU’s required template and language, develop visit schedule in OHSU’s CTMS, review study feasibility, and provide additional support as needed. 

Required Qualifications

• Master’s Degree in relevant field OR

• Bachelor’s Degree in relevant field AND 2 years of relevant experience

• Strong written, verbal comminication and proficeincy in MS Office Suite; meticulous record keeping and organization skills.

• Working knowledge of IRB guidelines and FDA, DHHS, other agency guidelines that govern clinical research.

• STATA, SAS, R, SPSS, or other statistical software.

Preferred Qualifications

• MPH in Epidemiology or Biostatistics, or currently working toward MPH in Epidemiology or Biostatistics
• 2-3 years of experience in clinical research including at least 2 years of data analyses, database management, and communicating with stakeholders.
• REDCap database management.
• Experience with EndNote or other citation software.
• Good Clinical Practice (GCP) Certification, SOCRA or ACRP Certification
• Phlebotom