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Principal Statistician (Clinical Research)


Santa Rosa, CA 95404
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Job Details

Principal Statistician (Clinical Research)


Santa Rosa, California, United States

Requisition #:


Post Date:

Dec 14, 2020

**Careers That Change Lives**

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

Join a diverse team of innovators
who bring their worldview, their unique backgrounds, and their individual life
experiences to work every day. Its no accident we work hard to cultivate a
workforce that reflects our patients and partners. We believe its 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 at

The Structural Heart Business is one
of the fastest growing businesses and helps patients all over the globe needing
valve replacement. The Coronary and
Structural Heart (CSH) provides interventional devices to treat coronary
arteries that are blocked by atherosclerotic plaque and devices and therapies
to treat structural defects of the heart.

_This is a remote based role so the candidate can live anywhere inthe U.S._

Preferred location: Santa Rosa, CA

**A Day in the Life**

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

+ Designs, plans and executes biostatistical componentsof plans for research and development projects that establish theconditions essential for determining safety, efficacy, and marketabilitymedical device products.

+ Uses sound statistical methodology to conduct studiesrelating to the life cycle of the product.

+ In development-phase projects, prepares the statisticalcomponent of protocols which meet project objectives, health authorityguidelines, and clinical trial methodology standards.

+ Develops and/or applies statistical theories, methods,and software.

+ Summarizes and interprets data into tabular andgraphical formats amenable to principles of statistical inference and isresponsible for the statistical component of reports describing studies,outcomes and methods used.

+ Provides specifications and directions to theclinicians/statistical programmers.

+ Supports the regulatory review and approval of theexperimental therapies.

+ May partner in trial design and in establishingstandards for clinical conduct, and the collection, management and/orreporting of data.

Additional Responsibilities:

+ Applies statistical knowledge and experience to thedesign of clinical studies, ensuring that study objectives can bemet. This requires calculation of sample size and power, as well aspossible determination of appropriate design assumptions.

+ In development-phase projects, prepares thestatistical component of protocols which meet project objectives, healthauthority guidelines, and clinical trial methodology standards.Assists in development and review of case report forms,ensuring data will be collected efficiently and accurately.

+ Identifies potential threats to study credibility andvalidity, and works with study team to prevent, track, and managepotential problems.

+ Interprets statistical and clinical findings, andensures that regulatory submissions, reports, and manuscripts accuratelyreflect the data collected.

+ Writes Results and Methods sections of clinicalreports, abstracts and manuscripts as needed.

+ Consults with other (e.g. non-clinical) staff onstatistical and analysis issues.

**Must Have (Minimum Requirements):**

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

+ Bachelors degree witha minimum **7** years of statisticsexperience (e.g., statistical/biostatistics analysis) in the healthcareindustry, or advanced degree with a minimum of **5** years of statistics experience (e.g.,statistical/biostatistics analysis) in the healthcare industry.

**Niceto Have (Preferred Qualifications):**

+ **Advanceddegree in Biostatistics or Statistics or math**

+ Experience as a Biostatistician at Medtronic or for amedical device or healthcare company

+ Deep knowledge of statistics and data analysis(statistical modeling, Bayesian inference, adaptive design)

+ Experience working with large data sets

+ Extensive SAS or R programming experience

+ Experience in Good ClinicalPractice (GCP) and/or regulatory compliance guidelines for clinical trialsand medical devices (e.g. ISO, MDD/MDR, CFR)

+ Demonstratedability to communicate technical content to non-statisticians (written andverbal)

**About Medtronic**

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. Lets 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

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)

Travel up to 10%
(Domestic and International).

**Check out**
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.
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