Senior Statistician - Diabetes (remote within the US) at Medtronic in Northridge, California

Job Description:

Careers That Change Lives

In this exciting role as a Senior Statistician, you will have primary focus responsibility to statistical support of clinical studies for Diabetes devices.

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, developing 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.

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.

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

Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.

Preferred locations: Northridge, CA but open to remote within the US

Ability to travel up to 10% (primarily d omestic and may have some international travel).

A Day in the Life

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.

• 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.
• 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.
• Provides specifications and directions to the clinicians/statistical programmers.
• Supports the regulatory review and approval of the experimental therapies.
• Identifies potential threats to study credibility and validity, and works with study team to prevent, track, and manage potential problems.
• Writes the statistical analysis plan for the study, if required.
• 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.

Must Have (Minimum Requirements):

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

• Bachelor's degree and a m inimum of 4 years of statistics/biostatistics experience or advanced degree with a minimum of 2 years of statistics/biostatistics experience

• Advanced degree statistics or biostatistics or math
• 2+ years post graduate experience in medical research
• Clinical trial design and data analysis in medical and diagnostic devices
• Diabetes therapies/products experience.
• Extensive and recent experience in the following:
  
  
  • SAS and/or R
  • Statistical methods (e.g., survival, regression)
  • Statistical and/or clinical report writing (e.g., writing or updating clinical reports/documents) and demonstrated ability to communicate (written and verbal) technical content.
  
  
• Experience in FDA and/or global regulatory submissions
• Experience with propensity score analysis, mixed-effects models, Bayesian adaptive designs, meta-analysis, real word evidence, modeling & simulations
• Experience in handling of protected patient health information
• Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g., ISO, MDD/MDR, CFR)
• Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology.
• Excellent prioritization and organization skills
• Ability to work in a highly matrixed environment
• Proficiency in MS Office applications (Excel, PowerPoint, Word)
• Experience working with large data sets.

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

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)

Ability to travel up to 10% (primarily d omestic and may have some international travel).

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits at benefits.medtronic.com

Additional Information

• Posting Date: Jan 14, 2022
• Travel: Yes, < 25 % of the Time