In this exciting role as a Clinical Research Specialist, you will have primary focus responsibility in preparing sites for data collection, relationship building with research coordinators, regulatory report writing, and data cleaning. The CRS works under the direction of a Clinical Study Manager and assists with numerous tasks associated with the execution of a clinical trial. The Study & Scientific Solutions (S&SS) is a function within Medtronic Core Clinical Solutions (MC2). S&SS is an internal service provider to all of Medtronic and assigns resources to assist Business Units execute on clinical trials and scientific projects when they have an increase in workload. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and non-registered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interprets results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site and vendor selection. Represents Medtronic from a clinical research perspective within the country/region and collects feedback from local customers and authorities. Builds and maintains optimal relationships and effective collaborations with various internal and external parties. Drives local evidence dissemination & awareness.

• Join our Clinical Research team as a Principal Scientist in Biostatistics • Contribute to advancing life-changing therapies through statistical excellence • Work closely with clients while utilizing the benefits and resources of Thermo Fisher Scientific • Responsible for implementing diverse statistical tasks throughout the full clinical trial process, from study design and protocol writing to final analysis and reporting • Opportunity to impact health outcomes while working with advanced clinical development programs

• The Lead Biostatistician functions independently as a project lead or lead statistician to deliver the project tasks/responsibilities. • Performs project management functions relating to the administrative and scientific activities of specific project work and team members. • Oversees statistical aspects in the design and analysis of clinical trials, including project management, statistical analysis, report preparation, and advising other project statisticians. • Supports the department by directly contributing to simple or moderately complex study protocols and bid defenses, including organizing teams and implementing strategies to ensure process and programming efficiencies.

• Providing statistical support to clinical studies • Participating in the development of study protocols, including participation in study design discussions and sample size calculations • Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Performing statistical analyses and interpreting statistical results • Preparing clinical study reports, including integrated summaries for submissions • Utilizing your strong communication skills to present and explain the methodology and consequences of decisions • Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions. • Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros • Participate in the development of CRFs, edit check specifications, and data validation plans • Provide review and/or author data transfer specifications for external vendor data • Collaborate with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals • Provide review and/or author SOPs and/or Work Instructions related to statistical programming practices