Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Our location in Santa Clara, CA (or Remote) currently has an opportunity for a Principal Clinical Data Scientist.
Using a full range of analytical tools (such as AI/ML) and a variety of data sources (such as clinical studies, real-world data), this role is responsible for the generation of clinical evidence in order to support product development, label expansion, publication/presentation, and business intelligence, etc. Assist on the design, analysis, interpretation and documentation of statistical results. Provide statistical consultation to technical staff, management, and regulatory agencies. Develop statistical material and presents/interprets findings to cross-functional stakeholders.
WHAT YOU’LL DO
- Ensure clear achievable purpose and scope definition. Responsible for design and statistical methodology selection, sample size justification, randomization order and protocol acceptance criteria.
- Statistical Data Analysis - Assist study owners on implementing statistical methodologies as defined in the protocol and on defining alternative analysis strategies when changes are needed. - Assist on data analysis and results interpretation. - Assist on the software validation of statistical programs.
- Assist project team on data interpretation, inferences and documentation of statistical results.
- Assist peers to develop efficient designs, protocols and reports per agreed timelines.
- Presents statistical concepts and arguments to management, regulatory agencies and scientists.
- Train, Mentor, and Develop statistical modules and provide formal training to statisticians and non-statisticians.
- Project Coordination and Regulatory Activities - Responsible for the accuracy and appropriateness of statistical inputs provided for regulatory submissions and development decisions.
- Identifies issues, problems, or opportunities and determines whether action is needed. - Encourages others to generate options for action to address and issue or problem. - Encourage boundary breaking by challenging colleagues to question established work processes.
- Effective communication with various levels of personnel is required regularly.
- Work collaboratively with multiple stake holders to develop scientifically appropriate strategies.
- Effectively and persuasively presents statistical concepts and arguments to management, regulatory agencies, scientists and non-scientists.
- Keeps informed of trends and new developments in analytics methodology (specifically AI/ML), technology, and data sources to better advise management of means to accomplish analytics goals
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelors Degree in Statistics or related field.
- Minimum 9 years of related work experience.
- Technical and High degree of technical competence and communicative ability, both oral and written.
- Competent in experimental designs, sampling plans, equivalence studies, confidence and reliability testing and statistical analysis for test method evaluation among others.
- Knowledge in appropriate statistical software such as JMP, Minitab or SAS. Business and Comprehensive knowledge of business concepts, procedures, practices, unit functions and cross group dependency/relationships.
- Cognitive Skills and Experience working with complex problems where analysis of situations and data requires in-depth evaluation of various factors.
- Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- Influence/Leadership and Ability to interface with a variety of management levels on significant matters, often requiring the coordination across organizational units.
- Participates in the development of others by facilitating training and providing feedback and guidance.
- Ability as a mentor to less-experienced staff and capable of leading a team.
- Plans and organize project assignments of modest variety and complexity.
- Ability to initiate and maintain schedule for projects and milestones.
- Masters Degree or/and Doctorate Degree
- Related work experience within medical device or pharmaceutical industry
- Artificial intelligence (AI) and machine learning (ML) experience
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.