Executive / senior industry position
Careers That Change Lives
Help lead the effort to create global strategies for worldwide medical device approvals to introduce new products to market. Bring your talents to a leader in medical technology and healthcare solutions. Rooted in our long history of mission-driven innovation, our medical technologies open doors. We support your growth with the training, mentoring, and guidance you need to own your future success. Join us for a career that changes lives.
In this exciting role as a Senior Statistician, you will have primary focus responsibility to statistical support of clinical studies for Structural Heart devices.
Cardiac and Vascular Group (CVG)
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic, Peripheral and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.
Coronary and Structural Heart (CSH) provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.
Responsibilities may include the following and other duties may be assigned.
- Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions.
- In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.Assists in development and review of case report forms, ensuring data will be collected efficiently and accurately.
- Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems.
- 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.
- May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
- Writes the statistical analysis plan for the study, if required.
- Provides specifications and directions to the clinicians/statistical programmers.
- Supports the regulatory review and approval of the experimental therapies.
- Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manuscripts accurately reflect the data collected.
- Writes Results and Methods sections of clinical reports, abstracts and manuscripts as needed.
- Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
- Attends and contributes to project and department meetings.
- Extensive SAS or R programming experience
- Experience working with large data sets
- Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
- Experience writing or updating clinical reports/documents.
- Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR)