Data Management Analyst II

4 weeks ago

Gainesville, United States University of Florida Full time

Job Description:

This position is located in the Department of Biostatistics, jointly housed in the UF College of Public Health and Health Professions and the College of Medicine. Responsibilities include data management, statistical analysis, and generation of interim reports for pediatric cancer clinical trials, specifically providing support for the Acute Lymphoblastic Leukemia Disease Unit conducted by the Children’s Oncology Group (COG). With minimal and general instructions, this individual must be able to work independently, collaborating with peers and COG Lead statisticians (faculty) for the Acute Lymphoblastic Leukemia Disease Unit across locations in Gainesville, FL, Memphis, TN, and Monrovia, CA. The incumbent will perform programming and statistical analysis tasks, ensuring their work meets a high standard of quality and is completed efficiently and with dedication to meet COG and clinical investigator project deadlines.

Manage data file systems from clinical trials and biospecimen banks that include multiple data sets. Initiate data quality checks for the assigned clinical trials. Adapt and develop programs for the selection of patient cohorts from COG clinical trials with specified inclusion criteria for approved correlative biology projects requiring biospecimens from the COG biobank in Columbus, Ohio; send de-identified patient data to the biobank for sample selection and shipping. Follow instructions from the clinical investigators and complete the biobank-related tasks with a high level of independence. Conduct statistical analyses correlating the results from the biology assays with clinical data from the COG trials.

Conduct requested ad hoc analyses and prepare summary reports for the trial committee applying a good understanding of the design and analytic plan in assigned trial protocols. With minimal supervision from the lead study statistician (faculty), understand and implement the protocol-specified interim monitoring and final analytic plan based on an outline provided by the study statistician. Interpret results for assigned clinical trials by employing knowledge of various statistical data analyses methodologies including survival analysis, cox regression analysis, logistic regression, and tests of association. Draft semi-annual study progress reports and confidential data safety monitoring committee reports using existing templates for study chair and statistician. 

Review and study the assigned clinical trials, and the data collection case report forms developed for each. Programmatically conduct regular checks on the trial data, identify data inconsistencies, and work with the study Research Coordinator to resolve the data issues with participating sites.

Collaborate with study committees and study statisticians on abstracts and presentations at national and international conferences, and manuscript submissions to peer-reviewed journals; prepare summary reports of requested analyses including interpretation of results, prepare tables and high-quality figures for presentation at conferences and inclusion in manuscripts.

Work with COG Industry liaisons to prepare trial datasets for transfer to industry collaborators to help with regulatory submissions to the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Prepare datasets for required data upload submissions to the National Institute of Health (NIH) National Library of Medicine (clinicaltrials.gov). 

Complete other duties as assigned. 

Expected Salary:

$, - $, annually; commensurate with qualifications and experience

Minimum Requirements:

Master's degree in an appropriate area; or a bachelor's degree in an appropriate area and two years of relevant experience.

Preferred Qualifications:

1) A master’s degree in Statistics, Biostatistics, or related field;
2) Diverse skills in data management, programming, and statistical methods;
3) Proficiency in programming languages, including SAS, R, SPSS, Stata, and Excel;
4) Ability to work independently, take initiative, efficiently manage time and work with limited oversight; and
5) Ability to analyze problems and make sound judgments.

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