The SANTE (Sauver avec l'Azithromycine en Traitant les Femmes Enceintes et les Enfants) study is a large randomized trial being conducted in Mali, West Africa. Dr. Karen Kotloff is the study principal investigator (PI) and is based at the Center for Vaccine Development and Global Health at the University of Maryland, Baltimore (UMB). Dr. Kotloff oversees a study management team that includes faculty and staff at UMB as well as subject-matter experts based at other institutions. Along with Dr. Samba Sow, the local PI, she also oversees the research team at the Center for Vaccine Development in Bamako, Mali (CVD-Mali) in West Africa.

The SANTE study is based on exciting new findings that periodic administration of the antibiotic azithromycin reduces infant mortality in low resource settings. The SANTE study will provide pivotal data to determine whether azithromycin given as part of routine care of pregnant women and young infants has the same benefits. The study began enrollment in September 2020 and is expected to complete follow up by approximately February 2024. The target sample size is 49,600 mother-infant pairs in rural Mali, as well as an additional 12,000 infants (111,200 individuals in total).

Data for the trial are being entered offline using handheld tablets at a network of 80+ health facilities in rural and urban Mali. After entry, the data are synced to a central server that is hosted by the study data coordinating center (DCC). The study data platform is proprietary software that has been developed by the DCC and customized to meet the needs of the SANTE study.
The primary role of the Lead Research Analyst (SRA) will be to write programs for the purpose of data management and data analysis for the SANTE trial. The SRA will work closely with a dynamic team at University of Maryland School of Medicine and external collaborators (including PI, epidemiologists, biostatisticians, and the senior research coordinator), the study team at CVD-Mali, and the DCC. A key part of the SRA role will be to liaise between these groups for the purpose of data cleaning and quality control and to ensure good communication at all times. Specific duties are listed in the primary duties section below.
The SRA will accomplish these responsibilities by applying specialized and theoretical knowledge, principles, and concepts of a professional discipline normally acquired through advanced education or specialized training. He/she will work to resolve issues relating to the study data by utilizing independent judgment, creativity, and analytical thinking. He/she is expected to contribute to the development and evaluation of study goals and objectives.

The SRA will apply intermediate level knowledge, concepts, principles, and skills. His/her supervisors will define the goals and objectives of the role to align with the evolution of the study. It is important that the SRA is able to independently anticipate needs and requirements to resolve non-routine matters.

Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. This position is required to be vaccinated against COVID 19. For additional information on protocols and exemptions, please visit the COVID-19 website.

Benefits:

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

Primary Duties:

• The primary duty of this position will be to ensure high quantitative and qualitative data quality for a very large clinical trial dataset. Particular attention will be paid to data cleaning and troubleshooting data issues, in conjunction with the DCC and study team members. Specific duties to achieve this aim are described below.
• Uses subject matter and technical expertise to identify and define research questions and data elements, and integrates them into research design.
• Routinely download and merge data from the central server and store these files locally on Dropbox or another shared platform.
• Develop and maintain code for the purposes of routinely cleaning the study data. Re-code existing code as a quality control check and develop code for new queries as needed.
• Summarize and communicate data related issues, including specific queries that require resolution to the appropriate parties. This might include the study management team, the DCC, the data manager in Mali, or clinical study team member in Mali, among others.
• Attend and participate in regular meetings with team members based in the US and Mali.
• Maintain a log of data issues and the appropriate resolution, including any necessary follow-up. The SRA will liaise with necessary parties to ensure issue resolution.
• Routinely prepare data reports to be presented at weekly team meetings.
• Assist in the preparation of data reports for the data safety and monitoring board (DSMB), for study funders, and for meetings/presentations, as well as ad-hoc data reports.
• Prepare data files for statistical analyses and conduct simple statistical analyses using study data.
• Design and conduct quantitative research projects, analyze findings, develop conclusions, develop and write reports, prepare presentations of relevant findings and conclusions, and recommend appropriate actions.
• Establish and maintain database files, perform required data extraction through programming and report on progress of programs, studies and/or projects.
• Demonstrate expertise in statistical applications such as SPSS, SAS, R, STATA and/or Excel.
• Provide guidance, training, and mentoring to less experienced personnel in qualitative and quantitative analysis.
• Perform other related duties as assigned.