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 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