Clinical Scientist II bei Alphatec Spine

Description

Contribute to the advancement of ATEC’s spine surgery technologies by supporting clinical research and scientific evidence generation efforts. Working cross-functionally, this role will lead study design and protocol execution, management and analysis of datasets, and translation of findings into clear technical documentation and scientific communications that demonstrate product value and clinical impact.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Partner cross-functionally with Marketing, Regulatory, R&D to identify evidence gaps and align research studies with product and business objectives.
• Build relationships with key opinion leaders (KOLs) to generate clinician collaboration and relevant research projects, building and growing customer and investigator relationships that drive credibility in our products and organization.
• Lead the design of clinical research protocols evaluating ATEC’s implant, biologics and surgical procedure portfolio, incorporating rigorous statistical methodology, including endpoint selection, power calculations, and statistical analysis plans.
• Organize and manage large datasets data from research studies, ensuring accuracy, traceability, and proper documentation.
• Compile, critically analyze, and interpret research data across multiple data modalities.
• Prepare clear, complete and accurate technical engineering documentation.
• Contribute to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral; assist investigators or customers in the preparation and delivery of research results.
• Collaborate closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the research activities within the team.
• Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum of Bachelors' degree in a field of science or engineering required, MS or PhD preferred. At least 2 years of medical device experience required (spine industry a plus).
• Knowledge, understanding, and application of the conduct of clinical investigations involving humans in accordance ICH/GCP, US Code of Federal Regulations (CFR), and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki;
• Proficiency in conducting literature searches and critically evaluating and communicating findings.
• Strong understanding of clinical research and statistical/analytical methods.
• Strong technical writing skills with ability to communicate results to internal and external customers.
• Knowledge of orthopedics research, particularly spine, is a plus;
• Familiarity with electronic data capture systems (EDC, EMR), data analysis, and data visualization.
• Experience in technical writing, peer-reviewed literature retrieval and publishing.
• Detail-oriented, resourceful problem solver, with effective organizational skills.
• Ability to work in a fast-paced environment.