Job Description:

Careers That Change Lives

The Diabetes Operating Unit focuses on improving the lives of those within the global diabetes community. As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. We're committed to meeting people with diabetes where they are in their journey, always with an aim to make their lives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.

In this exciting role as the Principal Data Scientist - Real World Evidence (RWE) within the Diabetes Operating Unit, you will be responsible for developing and overseeing scientific and clinical evidence strategies to support the development and advancement of best-in-class diabetes therapies.

Areas of contribution will include clinical consulting to identify, develop and execute new real-world clinical research, data evidence optimization and overall strategy for the Real-World Evidence program. The Principal Data Scientist will collaborate with other members of the Diabetes Data Science and Clinical Teams, Evidence Optimization Group and Medical Science Teams and other cross-functional stakeholders (e.g., Research and Development, Corporate Biostats, Regulatory Affairs, Clinical IT, and others). The Principal Data Scientist collaborates, build relationships, and communicates effectively with a large group of internal and external stakeholders in a rapidly changing landscape, while managing the timely completion of deliverables.

A career at Medtronic is like no other. We're purposeful. We're committed. And we're driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide. We believe that when people from different cultures, genders, and points of view come together, innovation is the result - and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

Preferred location: open for remote within the U.S.
Ability to travel up to 25% domestic and international.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Leads the design, plan and conduct of the biostatistical components that evaluate the safety, efficacy, and marketability of Diabetes therapeutic and diagnostic products as well as industry-wide strategic initiatives in diabetes management.
• Uses sound statistical methodology to conduct studies relating to the life cycle of the product and leveraging various Real-World Data (RWD) (, e.g., Real-world registry, device recorded diagnostic, therapeutic and performance data logs and meta-analysis, etc) with protocols which meet project objectives, health authority guidelines, and Real-World Evidence (RWE) methodology standards
• Advises and guides the analytics group on the governance, data treatment, quality controls and digital infrastructure required for the generation of RWE projects and publications.
• Prepares the statistical component of RWE protocols, and/or Statistical Analysis Plans. Supports the regulatory review and approval of the therapies through use of RWD.
• Ability to independently design and execute on projects using cutting-edge data science tools and technologies
• 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 RWD analysis.
• Maintains substantial knowledge of state-of-the art principles and theories and may contribute to scientific literature and key scientific conferences, helping to build relationships with KOL advisors
• Serve in an advisory role to management to provide direction and guidance to teams to execute initiatives and/or programs. Presents statistical results to non-statisticians, exchange information of facts, statuses, ideas, and issues to achieve objective, and influence decision-making.
• Work within established teams to provide clinical subject matter expertise (familiarity with OU clinical strategies, pre- and post-market evidence needs, product positioning, Real-World study design approaches, including endpoint and product performance goal definitions), operational aspects of Real-World Evidence generation in in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations

Must Have:
To be considered for this role, the minimum requirements must be evident on your resume.

• Bachelor's degree in a Technical discipline required with a 7+ years of statistics/biostatistics or clinical research experience, or advanced degree with 5+ years of statistics/biostatistics or clinical research experience.

Nice to Have:

• PhD, Master's degree in Life Sciences/Public Health, statistics/biostatistics, computer science, mathematics, systems engineering, biomedical engineering or related field
• Demonstrated proficiency in Python, preferred. Experience in Matlab, R or SAS with willingness to convert to Python acceptable.
• Clinical study data management and design, data analysis/reporting
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for real-world evidence studies or clinical trials (e.g., ISO, MDD/MDR, CFR)
• Experience working on alternative data sources and alternative methods of clinical data collection, especially those enabled by technology platforms and/or solutions.
• Prior experience in FDA and/or global regulatory submissions
• Experience with adaptive designs, Bayesian modeling, sequential data, computational statistics
• Understanding of statistics and machine learning methods, ability to continue self-learning of technical and non-technical skills
• Experience communicating complex statistical/machine learning results to technical and non-technical through journal publications, conferences, presentations/posters, and seminars
• Experience in processing large data from various data sources
• Experience in handling of protected patient health information

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

• Posting Date: Sep 17, 2021
• Travel: Yes, < 25 % of the Time

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