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 perform as a project statistician to support cardiovascular device clinical trials.
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.
Cardiac Rhythm and Heart Failure (CRHF) is a business division within CVG which offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
Responsibilities may include the following and other duties may be assigned.
- Designs, plans and executes biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of pharmaceutical and/or biological products.
- Uses sound statistical methodology to conduct studies relating to the life cycle of the product.
- In development-phase projects, prepares 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.
- Provides specifications and directions to the clinicians/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.
- Prepares the statistical component of protocols, and/or Statistical Analysis Plans which meet project objectives, health authority guidelines, and clinical trial methodology standards. 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 analysis 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, validation, and other Standard Operation Procedures and requirements.
- Bachelor’s degree required
- Minimum of 4 years of statistics (e.g., statistical modeling, biostatistics, data analysis) experience, or advanced degree with a minimum of 2 years of statistics (e.g., statistical modeling, biostatistics, data analysis) experience
- Proficient in SAS; Prior experience in FDA and/or global regulatory submissions
- Experience in processing large data
- Experience in handling of protected patient health information
- 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)