Description
Oversee the full life cycle of multicenter randomized clinical trials including study design and implementation; data collection tool development; data quality assessment and ongoing monitoring; regulatory reporting; statistical analysis; interpretation of results and manuscript writing for the Peripheral Artery Disease (PAD) research group. Ensures that all activities are completed by strictly following Good Clinical Practices (GCP) & all current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH).
Specific Responsibilities
Technical
- Oversee the full life cycle of multicenter randomized clinical trials including study design and implementation; data collection tool development; data quality assessment and ongoing monitoring; regulatory reporting; statistical analysis; interpretation of results and manuscript writing.
- Engage in both ongoing studies and grant proposal development, including the pursuit of funding for National Institutes of Health (NIH) supported data coordinating center opportunities.
- Participating as a co-investigator on ongoing randomized clinical trials and longitudinal observational studies and planning randomized clinical trials, including participating in Zoom meetings to discuss preparations for NIH and other grant proposals, and to discuss data analyses, outcome measures, manuscript development for proposed and completed studies.
- Managing and analyzing large datasets, such as RNA sequencing libraries.
Supervision
- Teaching Master-level data analysts and physicians, PhD, and pre-doctoral scientists in data analyses and data interpretation.
- Performs other duties as assigned.
Minimum Qualifications
- Master’s degree in statistics or a related field.
- One year of prior working experience in conducting sophisticated statistical analysis including longitudinal data analysis and survival analysis.
- One year of prior working experience providing statistical support and presenting outputs within a clinical research team.
- One year of prior working experience programming with SAS and/or R.
