AI & Bioinformatics Digital Health Programmatic Technical Advisor The Opportunity: To achieve an organization’s mission, leaders need strong team members who can develop innovative solutions, evaluate the latest technologies and strategic initiatives, and manage projects, programs, and
Location:Washington,DCmetropolitanarea,includingRockville,SilverSpring,andBeltsville,Maryland WorkArrangement:Localhybridposition.RemoteworkmaybeauthorizedbyFDA,buttheemployeemustbeavailableforonsitemeetingsandactivitieswhendirected. Schedule:MondaythroughFriday,generally8:30AM-5:00PMEasternTime SecurityRequirement:MustbeabletoobtainaTier2PublicTrustbackgrounddeterminationandHSPD-12PIVcredential Compensation PayRate:$72.50-$74.86perhour PositionSummary Theanalystwillsupportthereceipt,preparation,loading,validation,review,andreportingofstandardizedclinicalandnonclinicalstudydatasets.ThepositionwillworkwithFDApersonnelandsubject-matterexpertstovalidateSDTM,ADaM,SEND,andrelatedCDISC-formatteddatasetsusingtheFDAsPinnacle21EnterpriseandDataFitenvironment. Theanalystmustbecapableofreviewingautomatedvalidationresults,comparingreportedfindingsagainstsourcedatasets,identifyingdata-qualityissues,andpreparingaccuratefindingsreportswithinFDAreviewtimelines. PrimaryResponsibilities RetrieveclinicalandnonclinicalsubmissiondatasetsfromFDA-designatedrepositories. CoordinatedatasetintakeandprocessingactivitieswithFDAemployeesandtechnicalpersonnel. PrepareanduploadSDTM,ADaM,SEND,andsampledatasetsintoPinnacle21Enterprise. Initiateautomateddatasetvalidationprocedures. Comparevalidationfindingsagainsttheunderlyingdatasets. Identifyerrors,inconsistencies,anomalies,andpotentialstandards-conformanceissues. Assistwithfiltering,characterizing,tracking,andreportingvalidationfindings. HelpdocumentrequirementsandchangerequestsassociatedwithPinnacle21Enterprise. SupportautomatedvalidationofFDAapplicationsandclinical-studysubmissions. Respondtofollow-upquestionsregardingvalidationreportswithinonebusinessday. SupportinitialvalidationfeedbackwithinrequiredFDAtimeframes. ProtectFDAinformationandControlledUnclassifiedInformation. RequiredQualifications UnitedStatescitizenship. Educationorprofessionalbackgroundinbioinformatics,computationalbiology,biostatistics,healthinformatics,lifesciences,datascience,orarelatediscipline. Demonstratedexperienceworkingwithstructuredscientific,clinical,biomedical,orregulatorydatasets. Experiencereviewingdata-validationresultsandinvestigatingdata-qualityissues. Stronganalytical,problem-solving,anddocumentationskills. Abilitytomeettime-sensitiveFDAsubmission-reviewdeadlines. Abilitytoworkeffectivelywithgovernmentpersonnel,scientists,dataanalysts,andtechnicalsubject-matterexperts. Strongwrittenandverbalcommunicationskills. PreferredQualifications ExperiencewithPinnacle21EnterpriseorPinnacle21Community. ExperiencewithCDISCstandards. ExperiencewithSDTM,ADaM,orSENDdatasets. ExperiencesupportingFDA,HHS,pharmaceutical,biotechnology,clinical-research,orlife-sciencesorganizations.
SMX Services & Consulting, Inc. is seeking a data analyst to support FDA submissions in the Washington, DC area. The role involves handling SDTM, ADaM, and SEND datasets, validating data quality, and preparing findings within FDA
AI & Bioinformatics Digital Health Programmatic Technical Advisor The Opportunity: To achieve an organizations mission, leaders need strong team members who can develop innovative solutions, evaluate the latest technologies and strategic initiatives, and manage projects, programs, and
Job Description SummaryPOSITION OVERVIEW/SUMMARY: The Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland (UMD), in collaboration with the UMD Center of Excellence in Microbiome Sciences, invites applications for a Postdoctoral
Online applications must be received before 11:59pm on:September 20, 2026 If a date is not listed above, review the Applicant Instructions below for more details. Available Title(s):270-NN_FACULTY - Assistant Professor, 395-NN_FACULTY - New Tenure-Track - Pre-Academic
Biostatistics and Clinical Trials Advisor The Opportunity: To achieve an organization’s mission, leaders need strong team members who can create processes, communicate requirements, and develop innovative solutions throughout the execution of the mission. Whether completing an
Position TitleAssistant Professor of Biology Employee TypeRegular Office/DepartmentBiology Work Environment Remote and hybrid positions are open to applicants based in states identified here: Work at Loyola | Loyola University Maryland.Loyola University Maryland Main Campus Job TypeFull
Description The Karchin Lab leads computational antigen discovery for a privately funded program developing the next generation of vaccines for the treatment and prevention of pancreatic cancer. The incumbent will develop new computational models and algorithms
The Center for Infectious Diseases in India (CIDI) in the Division of Infectious Diseases is seeking a Sr. Research Data Analyst (Sr. RDA) to lead analytics for multiple projects within the Center. The Sr. RDA will
IT@JH Research Computing is seeking a HPC Scientific Software Engineer to support faculty, researchers, and students engaged in high-performance and AI-driven research across Johns Hopkins University. The position is responsible for deploying, optimizing, and maintaining scientific
The Johns Hopkins Data Science and AI Institute (DSAI) is a new pan-institutional initiative at Johns Hopkins to advance artificial intelligence and its applications, in part through investments in the software engineering, data science, and machine
We are seeking an Associate Administrator - Clinical who will manage the financial and administrative activities of two (2) growing divisions: Divisions of Nephrology and Responsible AI, Data Sciences, and Education in Medicine (RAISE) Center at
The Johns Hopkins Data Science and AI Institute (DSAI) is a pan-institutional initiative at Johns Hopkins to advance artificial intelligence and its applications, in part through investments in the software engineering, data science, and machine learning
The Johns Hopkins Data Science and AI Institute (DSAI) is a pan-institutional initiative at Johns Hopkins to advance artificial intelligence and its applications, in part through investments in the software engineering, data science, and machine learning
The Johns Hopkins Data Science and AI Institute (DSAI) is a new pan-institutional initiative at Johns Hopkins to advance artificial intelligence and its applications, in part through investments in the software engineering, data science, and machine
Job Description Seeking a full time research coordinator who is creative, enthusiastic, and motivated for the Mulvaney lab at the Children’s National Research and Innovation Center in Washington, DC. The lab will be affiliated with the
Postdoctoral Associate Bennett Lab The Jackson Laboratory Bar Harbor, ME. The Bennett Lab is dedicated to uncovering the fundamental mechanisms that govern the developmental emergence of hematopoietic stem cells (HSCs) and translating these insights toward improved
Job Family:Scientist Travel Required:None Clearance Required:Ability to Obtain Public Trust What You Will Do: We are looking for a Senior Scientist to support the National Institute on Aging by leading and executing advanced laboratory research activities,
Job Family:Scientist Travel Required:None Clearance Required:Ability to Obtain Public Trust What You Will Do: We are looking for a Senior Scientist to support the operational and research objectives of the National Institute on Aging (NIA) Intramural