Director of Biostatistics (USA Remote)

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.

You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We are currently looking for a highly motivated Director of Biostatistics to join our Neurovascular Medical Science and Clinical Affairs group.

This position can be based out of Irvine, California, or remote within the United States.

In this role, you will influence and drive statistical strategy / innovation at advanced expert-level directly taking part in cross-functional collaboration and decision making for multiple programs, across multiple indications / therapeutic / disease areas within research and medical affairs.

You will be accountable for strategic statistical input and influence. You will use your proven leadership ability with excellent collaboration skills and ability to mentor and provide oversight and direct the activities for the statistician team.

You will represent the function at internal and external decision boards, develop and mentor other statisticians, and provide strategic, technical, operational and scientific leadership and solutions.

In this role you will have 6 to 10 direct reports. You will report to the Vice President of Clinical Research and Medical Science for Neurovascular.

Responsibilities will include but are not limited to :

• Expert level contribution to statistical strategy (design, analysis / synthesis, interpretation and reporting, regulatory response, influence and execute publication strategies) for critical clinical programs in the Neurovascular portfolio.
• Resource allocation, directing the scheduling of work assignments, and monitoring project status to assure timely completion of projects.
• Plan, direct, and coordinate a variety of specialized and complex clinical projects (must have knowledge of clinical design of experiments, clinical data management and programming tools, and ability to interpret results from clinical studies).
• Keep current on new developments and technological advancement in statistics.
• Design, plan and execute biostatistical components of plans for research and development projects that establish the conditions essential for determining safety, efficacy, and marketability of the technology and therapies.
• Use sound statistical methodology to conduct studies relating to the life cycle of the product.
• In development-phase projects, prepare the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.
• Develop and / or apply statistical theories, methods, and software.
• Provide scientifically rigorous statistical input into study design, statistical analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects.
• Summarize and interpret 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.
• Provide specifications and directions to the clinicians / statistical programmers.
• Support the regulatory review and approval of experimental therapies.
• May partner in trial design and in establishing standards for clinical conduct, and the collection, management and / or reporting of data.
• Plan, prioritize and oversee project level activities and ensure efficient resource management.
• Provide planning and communication of statistical analyses, data presentations and scientific reports, including clinical trial results, exploratory analyses and analyses that synthesize results across studies, support for publication activities, scientific presentations and support for product defense.
• Be accountable for timeliness and quality of study / submission level statistical deliverables on assigned projects. Ensure that all statistics activities are conducted in compliance with relevant regulatory requirements and Medtronic standards.
• May partner in establishing standards for clinical conduct, and the collection, management and / or reporting of data.
• Develop effective collaborations with colleagues within clinical teams, partner lines of other functioning areas, and external regulatory, industry and professional and academic organizations.
• Provide statistical input and directions to the clinicians / statistical programmers.

Must Have - Minimum Qualifications

To be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume.

• Bachelors degree required
• Minimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experience

Nice to Have

• Neurovascular medical device experience
• Breadth of diverse leadership experiences and capabilities including : the ability to influence and collaborate with peers, develop, and coach others, and oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• Experience effectively writing and verbally communicating to all levels internally and externally within a regulated environment.
• Experience effectively collaborating with different functional groups.

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.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. 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.

Salary ranges for U.S (excl. PR) locations (USD) : $204,800.00 - $307,200.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

This position is eligible for an annual long-term incentive plan. The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California.

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification / education, market conditions, and location.

Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people.

From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.

We have the talent, diverse perspectives, and guts to engineer the extraordinary.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law.

In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

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Remote working / work at home options are available for this role.