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

Title: Senior Epidemiologist (RWE)

Location: Remote

Clearance: Public Trust Eligible

About This Role

• Provide new programs and enhance existing programs for the generation and analysis of clinical evidence used in regulatory decision-making of medical devices
• OCEA 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 needs
• This 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 Support

We Are Seeking Professionals With Real World Experience With

• Master’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 management
• Advanced statistical methods and data analysis techniques in epidemiology
• Data from electronic health records, claims databases and other sources of RWD
• RWE 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 Have

• PhD or MD

Who We Are

• Rackner 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 Info

Rackner 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 PTO
• Great health insurance with large network of providers
• Medical/Dental/Vision
• Life Insurance, and short & long term disability
• Industry-Leading Weekly Pay Schedule
• Home 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