Analyst, Clinical Data Analytics THV

Socket.dev; California (MO); Hybrid; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences is seeking a Clinical Affairs analyst to forecast enrollment, costing, and resources for trials. You will work closely with investigators and regulatory teams to generate evidence supporting patient access to innovative devices.

The role emphasizes quantitative analysis, dashboard reporting, and collaboration across Clinical Affairs, Regulatory, and Strategy teams in a fast-paced environment.

Qualifications

• Bachelor's Degree and a minimum of 3 years related experience or equivalent work experience.
• Experience in quantitative or analytical field.
• Good written and verbal communication skills.

Responsibilities

• Perform analysis (e.g. enrollment, costing, resourcing) related to clinical trials to develop forecasting for key stakeholders.
• Investigate, assess and interpret clinical intel for strategic decision making to support business objectives.
• Modify analysis tools by leveraging existing clinical models and trial knowledge.
• Organize, analyze and create reports and dashboards to summarize challenges in clinical affairs projects.
• Lead portions of clinical projects in collaboration with stakeholders.
• Identify and propose process improvements in clinical affairs.

Skills

Analytical thinking

Communication skills

Team collaboration

Education

Bachelor's Degree

Tools

Excel

PowerPoint

MS Office Suite

Job description

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis (AS) and aortic regurgitation (AR) impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

You will make an impact by:

• Perform analysis (e.g. enrollment, costing, resourcing) related to clinical trials to develop forecasting for key stakeholders (e.g. Clinical Affairs, Regulatory and Medical Affairs, Strategy, Global Supply Chain, Finance
• Investigate, assess and interpret clinical intel for strategic decision making to support business objectives, while proposing moderately complex solutions and recommendations
• Modify analysis tools by leveraging existing clinical models (e.g. inventory, case management, headcount trial enrollment and site activations/deactivations) while utilizing clinical trial knowledge
• Organize, analyze and create reports, and dashboards to summarize moderately complex challenges in clinical affairs projects, programs and/or initiatives
• Lead portions of clinical projects in collaboration with stakeholders (e.g. vendors, cross-functional teams)
• Identify and propose process improvements as it relates to clinical affairs (e.g. screening process, physician training)

What you will need (Required):

• Bachelor's Degree and a minimum of 3 years related experience or equivalent work experience based on Edwards criteria
• Experience in quantitative or analytical field or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Experience working in clinical research in the medical device industry or equivalent work experience
• Proven expertise in Excel and PowerPoint and other MS Office Suite apps including Word and Access
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving, organizational, analytical and critical thinking skills
• Moderate knowledge and understanding of policies, procedures and guidelines relevant to data analytics within clinical trials
• Solid understanding of quantitative methodologies, techniques and tools
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $74,000 to $104,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.