Research Analyst Real World Evidence

Research Analyst Real World Evidence, Research Analyst Real World EvidenceAbout ICA ICA is an 8(a) certified small business consulting firm with a mission to advance public health safety through its work in Clinical Evidence Research and Data Analysis, Advanced Data Science, and Strategic Services. ICA has established itself as a critical partner of the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). In addition, ICA supports the Centers for Medicare & Medicaid Services (CMS), FDA's Center for Veterinary Medicine (CVM), and the Federal Aviation Administration (FAA). Our Clinical Evidence Collaboration team has been partnering with CDRH to evaluate medical device safety and effectiveness in the real world. With our innovative approach, ICA identifies ideal health organization partners and subject matter experts to capture real-world data and generate real-world evidence in support of medical device evaluation. The culture at ICA is intellectually curious, inclusive, and collaborative across all divisions. We are continually looking for new opportunities to partner with medical device stakeholders to harness real-world evidence and advance the use of real-world data. Qualifications for this role include: PhD in epidemiology, public health, or a related discipline 3-5 years of experience in designing and executing prospective or retrospective epidemiological studies, including database analyses Experience using large-scale anonymous patient level retrospective healthcare databases populated with EMR, claims, and/or registry data Strong ability to effectively manage competing priorities Ability to work both independently and in a collaborative, team environment Strong communication, presentation, and interpersonal skills, both written and oral Excellent problem-solving, analytical, and organizational skills US work authorization, ability to obtain Public Trust Clearance Responsibilities of this role include: Participate in design of extant clinical research projects Evaluation and refinement of study question(s) Contribute to and advise on discussion of study objectives, endpoints, and outcomes of interest, including recommendation of potential proxies when specific outcomes of interest are not available Evaluation of data dictionary provided by external study collaborators Generate background information of medical device or procedure under evaluation Provide review of draft study protocols, reports, and other client facing documents prior to initial submission with particular focus: Alignment of study objectives and endpoints Study methodology Capture of study outcomes Collaborate with other departments/divisions on ongoing projects, as needed, including Health Technology Assessment and Data Science to provide subject matter expertise Contribute to identification of project risks, with regard to study design, and propose mitigation strategies ahead of study execution, and throughout the study lifecycle, as needed Plan, coordinate, and present to internal and external stakeholders regarding project risks and mitigation strategies specifically related to study design Participate in development of trainings, SOPs, templates, and job aids Clearance:Applicants selected will be subject to a security investigation and will need to meet eligibility requirements for access to classified information; Public Trust clearance is required. Vaccine Status:ICA Global is a federal contractor working directly with the U.S. Government and federal agencies. Vaccination for the coronavirus disease 2019 (COVID-19) is a requirement for employment and applicants selected will need to provide the necessary documentation of their vaccine status. What we offer employees: Competitive salary Comprehensive benefits including health, dental, vision, disability and life insurance Flexible time off with 20 days paid vacation, plus sick days Paid time off for observance of federal holidays 401(k) plan with company match Tuition reimbursement program Remote work from anywhere within the continental United States Location:This is a remote position. Candidates must be willing to travel to the office, in Arlington, VA, for the occasional team/client meetings. DC Metro candidates are preferred. Five percent travel can be expected. Flexibility is expected of the employee to be available for client/team meetings if the employee lives outside the Eastern Time Zone. Additional Information: ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Apply For This Job Apply tot his job