Postdoctoral Researcher

Kelly Science and Clinical FSP is currently seeking a Post Doc Research Associate for a long-term engagement in the US with one of our Global Medical Device clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

The preferred location for the position is New Brunswick, NJ. Remote-based work will be considered for highly-qualified candidates. The salary is competitive for a research associate position.

Position Summary

The Medical Device Epidemiology and Real-World Data Sciences (MD Epi-RWDS) organization is an industry leader, on the cutting edge of conducting observational and epidemiologic research to support post-market safety and effectiveness, regulatory submissions, product development, product launches, value assessments, predictive analytics, machine learning, and business development of medical devices.

The team leads Real-World Data innovation and methodological excellence across the Medical Device sector, and provides skills and expertise in using real-world evidence to support label extension, product development, safety, value demonstration for payers, and other activities.

As a member of this highly-productive team, the Research Associate will have the opportunity to lead and co-author peer-reviewed manuscripts and conference presentations.

We are looking for a very talented and innovative individual to join our team and grow their expertise and career. The Research Associate will be involved in addressing research questions related to medical devices using a variety of analytical techniques applied to an expanding array of databases. The person will be responsible for assisting with projects and initiatives in areas of epidemiology, comparative research, predictive analytics, health economics, post-market safety evaluation and surveillance, and regulatory label extension.

Section II: Principal Duties & Responsibilities

The role will involve participation in various project teams and task forces in addressing issues raised by product teams or regulatory agencies, to provide epidemiologic, predictive analytic and/or health economic consulting to product teams, generate needed real-world evidence, and/or disseminate scientific information through technical reports or models, presentations, and publications in peer-reviewed literature, as agreed by the team.

Close collaboration with cross-functional teams involving market access, R&D leaders, data scientists, healthcare researchers, and healthcare providers is a key requirement of this position.

The position reports to Senior Director, MD Epi-RWDS, who reports to the VP of the department. Structurally within the department fits within the Office of the Chief Medical Officer.

Examples of specific activities will include:

• Leading or participating in projects to evaluate disease natural history, treatment patterns, patient journeys, safety and effectiveness of devices using clinical and surrogate endpoints, or benefit-risk questions for cardiovascular devices

• Managing projects and timelines

• Analyzing electronic healthcare databases such as electronic health records (EHRs), insurance claims data, hospital billing data, or registries
• Developing, reviewing, and writing study protocols, analytical plans, and study reports

• Conducting systematic reviews and meta-analyses

• Preparing posters for presentation at scientific conferences

• Participating in manuscript development, review and submission

• Presenting research to internal stakeholders or external audiences

• Participating in work streams / task forces to standardize research and analytical processes to improve efficiency and quality of deliverables

Section III: Education and/or Experience

• A minimum of a PhD in epidemiology, biostatistics, health services research, health policy and management, health economics or other related field is required.

• Knowledge of and experience with large electronic healthcare databases, especially EHRs, and clinical coding taxonomies such as the International Classification of Diseases, is preferred

• The candidate must have a sophisticated understanding of and the ability to analyze and interpret quantitative data using statistical software such as SAS, R, etc.

• Experience with writing methods sections of study proposals/ protocols/ or background epidemiologic material on specific disease or therapeutic areas is required

• The candidate must have strong written and verbal communication skills

• Experience with predictive modeling and machine learning is a plus

• Ability to collaborate and work as part of a team is required

• The position will require under 10% of time in travel

The MD Epi-RWDS Team covers a wide breadth of medical specialties and disease states.

This role will support the Cardiovascular and Specialty Solutions (CSS) group[RK2]

Cardiovascular & Neurovascular – The person will be responsible for assisting with various projects and initiatives supporting RWE needs for the Cardiovascular and Specialty Solutions (CSS) group.. Working in close collaboration with our business partners, the candidate will have an opportunity to lead protocol-driven studies in the area of cardiac ablation treatment for heart rhythm disorders, specifically evaluating the safety, effectiveness, outcomes, and utilization patterns of our therapeutic and ultrasound catheters. Other areas of RWE work would include mechanical thrombectomy treatment for acute ischemic stroke and endovascular treatment of intracranial aneurysm. Research-related activities will include preparing study protocols, leading study analysis, and developing manuscripts and conference abstracts and presentations.