Senior Statistician - Cardiac Rhythm Management

Careers That Change Lives
In this exciting role as a Senior Statistician, you will have primary focus responsibility to support innovative cardiovascular device clinical trials and contribute to efforts in the field of advanced analytics and data solutions.

You will be responsible for contributing to statistical aspects of clinical projects, including design, analysis and publishing of data from complex clinical studies and various data sources  for regulatory approval and clinical evidence generation.  This includes responsibility for strategic design of clinical studies, contributing to clinical investigational plans, composing statistical analysis plans, review of data collection methods and quality metrics, analysis and interpretation of data, and preparation of relevant sections of clinical evidence  reports and manuscripts.  Work will generally be done in collaboration with other statisticians and will be reviewed by the statistical managers and other stakeholders at key time points. 

Our Cardiac Rhythm Management Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure. It is comprised of four key businesses: Cardiac Pacing Therapies, Defibrillation Solutions, Patient Management, and Procedure Innovations. Together, we will transform the lives of people with cardiac arrhythmias and heart failure.

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident — we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. To learn more about Inclusion & Diversity at Medtronic Click Here
 
A Day in the Life

Responsibilities may include the following and other duties may be assigned.
•    Works with cross functional teams to  design, plan and conduct of the biostatistical components in research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of cardiac therapeutic and diagnostic products.
•    Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
•    In development-phase projects, contributes to the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
•    Develops and/or applies statistical theories, methods, and software.
•    Summarizes and interprets data into tabular and graphical formats amenable to principles of statistical inference and is responsible for the statistical component of reports describing studies, outcomes and methods used.
•    Collaborates with others to provide specifications and direction to the clinicians, other supporting statisticians and statistical programmers.
•    Supports the regulatory review and approval of the experimental therapies.
•    May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data. 

Key responsibilities: 
•    Contributes to the statistical component of protocols, and/or Statistical Analysis Plans. Supports the regulatory review and approval of the experimental therapies.
•    Works in a team environment; partners with project teams to support clinical conduct, including collection, management and/or reporting of data.
•    Performs statistical analyses utilizing various data sources (e,g., Real-world registry, device recorded diagnostic, therapeutic and performance data logs and meta-analysis, etc.)
•    Presents statistical results to non-statisticians, exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision-making.
•    Complies to good documentation, good coding practices, validation, and other Standard Operation Procedures and requirements.
•    Stay current with emerging data processing and analytical methodologies and technologies (e.g. deep learning, machine learning, big data, digital health) and evaluate business viability of such technologies in the development and conduct of clinical trials.