Details
Posted: 30-Jun-22
Location: Minneapolis, Minnesota
Salary: 45636.18 - 127758.42
Additional Information:
2 openings available.
The School of Public Health is committed to anti-racism and anti-oppression in our mission and operations. In pursuit of this goal, we consider an applicant’s record working with individuals from historically marginalized backgrounds, and experience identifying and eliminating systemic barriers to success in an academic environment. SPH seeks to increase the diversity of its workforce, we particularly encourage applications from those who belong to groups that have been historically underrepresented in our discipline, including those who are Black, Indigenous, and people of color, those with disabilities, and those from LGBTQIA+ communities.
The Coordinating Centers for Biometric Research (CCBR) in the Division of Biostatistics, School of Public Health at the University of Minnesota conducts international trials of infectious diseases. Most of these trials are conducted by INSIGHT, an international clinical trials network for which we are the Statistical and Data Management Center (SDMC). Over the past 2 years, INSIGHT has conducted 8 randomized trials of treatments for patients hospitalized with COVID-19; prior to COVID-19, trials for the treatment of HIV and influenza, and the prevention and treatment of Ebola virus disease were conducted. Trials are funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
MS level biostatisticians work as protocol managers at the CCBR on clinical trials. They perform a variety of tasks related to the design, conduct and analysis of studies. They work closely with others in the CCBR, including data management, drug management, regulatory/safety, and administrative staff. They also work closely with clinical researchers around the world, including at the National Institutes of Health. Typically, 3 or more statisticians at the CCBR who have a range of experience (e.g., faculty in Biostatistics or Statistics, MS level statisticians), are involved in each trial. This affords the opportunity for less experienced statisticians to learn from those more experienced.
At any given time during the planning and conduct of a trial, tasks performed will vary. Usually, protocol managers will work on a study from its development until it is complete, and results have been disseminated. Tasks for a new trial include:
- Drafting the data collection plans
- Creating case-report forms (CRFs)
- Drafting procedure manuals and other protocol materials
- Training sites on study protocols and procedures
- Carrying out interim and final analyses.
- Participation on calls and in meetings to write protocols and statistical analysis plans
Tasks for ongoing and completed studies include:
- Preparation of interim analyses (closed reports) for an independent data and safety monitoring board (DSMB)
- Data quality assurance (QA). including writing reports that are regularly updated on the INSIGHT web site
- Serves as point of contact at the SDMC for questions from international coordinating centers who coordinate the work of clinical sites.
- Data analyses to support the preparation of multiple scientific presentations and publications.
40% Time -- Collaboration with international coordinating centers, monitoring data collection, participation on calls and training
25% Time – Protocol-related activities, such as collaboration on of data collection plans, protocols, procedure manuals and case report forms
35% Time –Preparation of interim analysis reports and work on manuscripts and presentations for conferences and publications
We are looking for a candidate who is interested in global health and infectious diseases, the design and conduct of clinical trials, and working in a collaborative, dynamic and fast-paced environment.
Required Qualifications
- A Master’s degree in statistics, biostatistics or epidemiology
- Proficiency using SAS and/or R statistical software
- Documented communication skills
- Ability to manage and track multiple requests and projects simultaneously
Preferred Qualifications
- Project management experience