Clinical Research Specialist (Data Scientist)

Department of Health and Human Services

National Institutes of Health (NIH),

National Institute of Allergy and Infectious Diseases

The National Institute of Allergy and Infectious Diseases (NIAID), one of the largest institutes in the National Institutes of Health (NIH), and part of the Department of Health and Human Services (HHS), conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma, and allergies.

The Clinical Trials Research and Statistics Branch in the Division of Clinical Research (DCR), NIAID, is recruiting for a clinical research specialist (data scientist) position.

DCR provides multi-disciplinary NIAID-wide services to facilitate clinical research and manage special projects as directed by NIAID leadership. As such, DCR plays an integral role in facilitating the effective performance of NIAID research programs both domestic and international. This is accomplished through a multi-faceted approach to providing and supporting services vital to the research infrastructure, including oversight and management of intramural clinical research, program planning and management, regulatory monitoring and compliance, clinical protocol management, statistical consultation and research methodology, and clinical research capacity building.

DCR supports NIAID’s capacity to launch emergency research responses to high-consequence infectious disease threats with potential to cause epidemics, pandemics, or other significant public health events anywhere in the world but likely in regions with little to no clinical research infrastructure.

In support of NIAID’s research agenda, the Clinical Trials Research and Statistics Branch designs and supports clinical trials for infectious disease threats through innovative fit-for-purpose trial design, robust data management, sound statistical analysis, and effective communication across all areas of study operations.

The clinical research specialist (data scientist) interacts and coordinates with international clinical trial sites, ensuring they meet U.S. federal standards on data management, privacy protections, and data transfer procedures; serves as a subject matter expert and oversight manager with responsibility for providing scientific leadership and guidance to the planning, development, and implementation of information technologies and data solutions; and provides data and information management planning, development, and quality assurance for the assigned biomedical research program area(s).

The clinical research specialist (data science) also serves as a key liaison and point of contact on information systems and data management for the DCR program(s) for all interactions within and outside NIH and may serve as a contracting officer’s representative.

The clinical research specialist (data scientist) has a broad range of responsibilities that include, but are not limited to, the following:

• •    Provide scientific oversight, support, and assistance for clinical and laboratory research databases and their operations and applications, including optimizing and managing assigned clinical and laboratory databases
• •    Provide data management, project coordination, and support on changes for project needs
• •    Oversee implementation of database standards, procedures, and guidelines and participate in the planning of future database expansion, enhancements, and selection
• •    Diagnose and work with IT specialists to resolve problems in response to reported issues and research, evaluate, and help troubleshoot problematic trends and patterns in database requirements
• •    Facilitate communication and collaborative efforts with other partners, including other NIH institutes and centers and HHS agencies
• •    Advise on laboratory and clinical trial data collection/analyses and formulation of appropriate research questions; lead data management activities of clinical trial design and implementation in collaboration with clinicians, researchers, and biostatisticians
• •    Monitor ongoing research at established international clinical trials sites
• •    Collaborate with biostatisticians and principal investigators in the preparation of analyses, reports, and presentations for trial clinicians and stakeholders, funders/collaborators, data and safety monitoring boards, and manuscripts for publication

Qualifications

Required

• •    Expert knowledge of the science and practice of clinical trials as gained by a baccalaureate or higher degree in a health-related field (e.g., R.N., B.S.N., M.D.) or a scientific field (e.g., B.S., M.S., or Ph.D.) with clear relevance to clinical research
• •    Experience in clinical research/clinical trial conduct, management, or oversight, applying experimental theories and new developments to the solution of complex healthcare problems not responsive to treatment by accepted methods
• •    Expertise in clinical and laboratory data management and data science principles
• •    Strong background in medical science
• •    Experience overseeing and coordinating clinical research data management operations for an organization
• •    Knowledge of clinical trial methodology, clinical trial and medical record keeping, and quality assurance issues
• •    Experience evaluating and supporting complex and precedent-setting clinical research studies
• •    Expertise in applying data management concepts and techniques and project management principles and methods to support clinical research

Preferred

• •    Experience as a data manager and/or data scientist working with clinical trials
• •    Experience in identifying and analyzing problems and constructing solutions to a variety of scientific and program/project management issues affecting clinical trials
• •    Management experience/strong leadership skills
• •    Knowledge of clinical data management best practices and regulations
• •    Ability to work independently and make decisions based on available knowledge
• •    Ability to work well in a team-oriented environment
• •    Flexible and willing to perform other tasks as needed/assigned
• •    Excellent written and oral communication skills to communicate complex technical requirements to non-technical personnel and prepare and present briefings to senior management officials on complex/controversial issues
• •    Ability to plan, organize, manage, and coordinate multiple complex assignments and prioritize conflicting requirements
• •    Ability to understand and adhere to local cultural norms and political sensitivities
• •    Willingness to develop contracting officer’s representative expertise

To Apply

Visit vacancy announcement numbers NIH-NIAID-DE-24-12458147 (U.S. citizens) and/or NIH-NIAID-MP-24-12458247 (status candidates) to submit your application online through USAJobs.gov. The application period is open from August 12, 2024, until 11:59 p.m. Eastern Time on August 16, 2024.

This position is subject to a background investigation. Applications from women, persons from underrepresented groups, and persons with disabilities are strongly encouraged to apply.

US Citizenship is required.

Visit NIAID Careers for more information about working in NIAID’s dynamic atmosphere.

HHS, NIH, and NIAID are equal opportunity employers dedicated to diversity, equity, inclusion, and accessibility. NIH is dedicated to building a diverse community through its training and employment programs.