Epidemiologist, Sr. (RWE | Healthcare Outcomes / Medical Devices)(Remote)

Title: Senior Epidemiologist (RWE)Location: RemoteClearance: Public Trust EligibleAbout This RoleProvide new programs and enhance existing programs for the generation and analysis of clinical evidence used in regulatory decision-making of medical devicesOCEA needs a comprehensive multi-faceted approach that consists of conducting novel research, developing advanced data analysis tools using state-of-the-art AI/ML, and supporting scientific workload needsThis requirement includes tasks areas: Clinical Evidence Studies Systematic Literature Review (SLR) Advanced Data Analysis Tools Using State-of-the-Art Artificial Intelligence and Machine Learning (AI/ML) Performance Tracking of Regulatory Programs Clinical Evidence Research and Surge SupportWe Are Seeking Professionals With Real World Experience WithMaster’s degree or higher in Epidemiology, Public Health, Biostatistics, Medicine, Biomedical Engineering, or related field.5+ years; in real-world evidence (RWE) research, with a focus on healthcare outcomes or medical devices.Statistical software (e.g. SAS, R, Python) and database managementAdvanced statistical methods and data analysis techniques in epidemiologyData from electronic health records, claims databases and other sources of RWDRWE methodologies including study designs, patient registries, electronic health records and claims database analyses.Managing large-scale RWE projects, from conception through to execution and dissemination.Regulatory requirements and guidelines related to RWE in medical research and public health.Nice To HavePhD or MDWho We AreRackner is a software consultancy that builds cloud-native solutions for startups, enterprises, and the public sector.We are an energetic, growing consultancy with a passion for solving big problems for both startups and enterprises.Each of us enable digital transformation for large organizations through the newest in distributed technologies as we are laser focused on end-to-end application development, DevSecOps, AI/ML and systems architecture and our methodology focuses on cloud-first and cost-effective innovation.Our customers hail from a diverse, ever-growing list of industries.Benefits/Additional InfoRackner embraces and promotes employee development and training and covers the cost of certifications relevant to a position and the technologies/services provided . Fitness/Gym membership eligibility, weekly pay schedule and employee swag, snacks & events are offered as well!401K with 100% matching up to 6%Highly competitive PTOGreat health insurance with large network of providersMedical/Dental/VisionLife Insurance, and short & long term disabilityIndustry-Leading Weekly Pay ScheduleHome office & equipment plan#programmanagement #fda #medicaldevices #OCEA #ClinicalEvidenceStudies #SystematicLiteratureReview #SLR #AdvancedDataAnalysisTools #ArtificialIntelligence #AI #MachineLearning #ML) #PerformanceTrackingofRegulatoryPrograms #ClinicalEvidenceResearch #SurgeSupport #Epidemiology #PublicHealth #Biostatistics #Medicine #BiomedicalEngineering #Realworldevidenceresearch #RWE #studydesigns #patientregistries #electronichealthrecords #claimsdatabaseanalyses #python #PhD #MD