Program Manager, Sr. (RWE | Healthcare Outcomes / Medical Devices)

Title: Senior Program Manager (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:

  1. Clinical Evidence Studies

  2. Systematic Literature Review (SLR)

  3. Advanced Data Analysis Tools Using State-of-the-Art Artificial Intelligence and Machine Learning (AI/ML)
  4. Performance Tracking of Regulatory Programs
  5. Clinical Evidence Research and Surge Support

We are seeking professionals with real world experience in:

• Master’s degree or higher in Epidemiology, Public Health, Biostatistics, Medicine, Biomedical Engineering, or related field
• 5 years; Real-world evidence (RWE) research, with a focus on healthcare outcomes or medical devices.
• Data analysis and interpretations
• Knowledge of regulatory requirements and guidelines related to RWE in the medical device industry.
• Lead and mentor a team, managing resources effectively to meet project deadlines and objectives.
• Presenting complex RWE and concepts to a variety of stakeholders.
• Professional experience with 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

Nice to have:

• Statistical software tools like SAS, R or Python
• 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