Senior Director - CRM Clinical Biostatistics & Alternative Data Solutions

Careers that Change Lives

The CRM Clinical Biostatistics and Alternative Data Solutions (ADS)  Senior Director is responsible for managing the objectives, strategic direction, operations and staff of the Cardiac Rhythm Management (CRM) Statistics, Programming, and Data Management Managers and staff at various levels as well as the Alternative Data Sources Research Group. The CRM Clinical Biostatistics and ADS Director provides leadership in the overall operations of the group, ensuring compliance to regulations and standard operating procedures, as well as providing consultation and review of statistical and data management plans, clinical protocols, and reports. The director will collaborate with cross functional partners to ensure needs are met and ensure staffing levels are appropriate for the CRM, Mechanical Circulatory Support (MCS), Cardiac Ablation Solution (CAS) and Cardiac Diagnostics and Solutions (CDS) Operating Units. The Global Clinical Biostatistics (Sr.) Director will serve as a key member of the CRM Clinical Research Leadership Team and report directly to the Vice President of CRM Clinical Research Strategy and Clinical Operations.

What does it take to be a leader at Medtronic?  We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes.

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.

A Day in the Life

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

• Provide biometric leadership and guidance for the CRM clinical department
• Provide strategic direction for the Statistics and Alternative Data Sources Teams
• Accomplish results through the management of managers and their staff and through cross-functional partnerships with study teams and investigators 
• Provide overall leadership and direct the activities for the biometrics team in support of all CRM, MCS, CAS and CDS operating units to ensure that clinical studies are optimally designed, properly analyzed, and clearly presented to support new product development
• Manage domestic and international regulatory submissions and the maintenance and growth of existing products/therapies
• Ensure adequate training for employees by developing and evaluating their performance with the authority to hire, terminate, and promote
• Provide leadership in the assessment, application, and adaptation of appropriate clinical methodologies in support of clinical research efforts by keeping current with regulatory guidance and requirements in a global environment
• Lead and participate in department and corporate workgroups and functional excellence projects to refine and implement clinical, statistical, and data management processes/ process improvements
• Responsible for statistical resource planning for clinical projects and for the Annual Operating Plan (AOP)
• Attends, facilitates and contributes to the broader management team and department work group meetings
• Ensure projects are completed per committed schedules and that work output is of high quality and meets regulatory requirements and Standard Operating Procedures (SOPs)
• Becomes actively involved in daily operations when required to meet schedules or to resolve complex problem
• Work within and actively promote Medtronic’s Core Mission, corporate strategies, policies, procedures, and Code of Conduct

LOCATION: Remote option may be considered