Job Location: Irvine, CA
Analyst, Clinical Data Analytics (Remote, US) – Transcatheter Heart Valve (THV)
The Transcatheter Heart Valve (THV) clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide. As the Clinical Data Analytics Analyst/Programmer, you will play a critical role in our ability to deliver devices that maximize our patient’s recovery and quality of life by assessing data to improve operations within our Clinical Affairs operations. You will be responsible for the compilation and reporting of study metrics and serve as the subject matter expert for advanced data programming needs.
This role is 100% remote (anywhere in the US) but applicants must be open to traveling to the Irvine headquarter for training/team events as needed (up to 10%).
Responsibilities include, but not limited to:
Perform summary output analysis (tables, listings, graphs), provide high level summary of study trial status, compliance tracking, and fulfill data requests for stakeholders and clinical management.
Review and validate statistical programs and ensure that all appropriate program validation documentation to meet regulatory and company standards are consistently structured to permit efficient programming, reporting, and review.
Organize, analyze and create reports, and dashboards to summarize moderately complex workflows in clinical affairs projects, programs and/or initiatives.
Modify analysis tools by leveraging existing clinical models and systems while utilizing clinical trial knowledge. Integrate various workstreams and platforms available; provide automation, as needed.
Identify and propose process improvements as it relates to Clinical Affairs procedures (e.g. screening process, physician training, core lab management, etc.)
Other duties as assigned.
Minimum Requirements:
Bachelor’s Degree in Statistics, Mathematics, Computer Science or related field
3 years of previous related experience in statistical programming (SAS, Python, R, Stata, mCODE, etc.)
Preferred Qualifications:
Experience in clinical trials or clinical research
Additional skills:
Expertise in Excel, PowerPoint and MS Office Suite. Experience with Microsoft 365 including Power BI
Expertise in statistical programming (e.g. SAS, Python, R, Stata, mCODE, etc.)
Excellent written and verbal communication skills and interpersonal relationship skills
Good problem-solving, organizational, analytical and critical thinking skills
Solid understanding and knowledge relevant to statistical programming
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan – it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
EEO is the Law click here for more information regarding Equal Employment Opportunity
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice
Submit CV To All Data Science Job Consultants Across United States For Free
Leave a Reply