Senior Clinical Data and Biostatistical Sciences Manager - NMPH - Fridley, MN (Remote within US)

We anticipate the application window for this opening will close on - 28 Feb 2025

 

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 LifeIn this exciting role as a Senior Clinical Data and Biostatistical Sciences Manager, you will be responsible for clinical study design and associated statistical analysis development as well as assisting with other clinical evidence data sets within the Neuromodulation and Pelvic Health (NM&PH) Clinical Biostatistics team. This role will be responsible for managing and guiding a statistical team and working cross-functionally on clinical projects spanning several therapies. You’ll always have new challenges pursuing ideas that are exciting and innovative by driving critical thinking about healthcare problems and/or opportunities in addition to regulatory body needs to advance evidence strategies to support new and existing therapies.

Careers That Change Lives

In this exciting role as a Senior Clinical Data and Biostatistical Sciences Manager, you will be responsible for strategizing clinical evidence needs and ensuring high quality analyses of the data for therapies and devices that improve healthcare for millions of patients. the Neuromodulation and Pelvic Health operating unit covers a wide range of therapies and products for Brain, Pain and Pelvic Health. the Brain Therapies include deep brain stimulation for Parkinson’s disease, epilepsy, dystonia, and obsessive-compulsive disorder. The Pain Therapies use ablation catheters for cancer pain, pain stimulators for back and leg pain, and drug pumps for back pain and spasticity. The Pelvic Health Therapies offer stimulators for many types of overactive bladder issues.

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.

This is a local or remote based role so the candidate can live anywhere in the U.S. Preferred location includes Fridley, MN.

Ability to travel up to 25% (primarily domestic and may have some international travel).

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

• Manages and mentors the statistical team via project planning, analytic guidance, and document review.

• 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.

• Prepare and manage annual operating budget, the strategic plan and general department logistics and administration for this area of the clinical research organization.

• Perform other responsibilities as required.

Must Have:

• Bachelor's degree with at least 7 years of relevant experience, including 5+ years in a managerial role.

• OR Advance degree with at least 5 years of relevant experience, including 5+ years in a managerial role.

• Strong leadership and management skills to effectively lead and guide project teams.

• Expert level proficiency in Biostatistics, with broad understanding of related disciplines within the job functions.

Nice to Have:

The ideal candidate will not only meet the required knowledge and experience but will also have:

• Advance degree in Biostatistics preferred.

• Experience in Medical Device industry is highly preferred.

• Hands on experience in data science applied to clinical study data, including real world data (RWD).

• Proven ability to generate meta-analysis from complex and diverse data sets, such as RCTs and Registries.

#LI-MDT

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):$168,000 - $252,000

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

 

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

 

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

 

Further details are available at the link below:

Medtronic benefits and compensation plans

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.

Learn more about our business, mission, and our commitment to diversity here.

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.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.