Bay Area or Remote
Phone, Email, Postal Address:
# of Openings: 1
How to Apply:
Please apply directly to: firstname.lastname@example.org
iRhythm Technologies is redefining the standard for ambulatory cardiac monitoring. Combining patient-friendly bio sensing technology with uninterrupted ECG recording, Zio by iRhythm gives doctors the reliable data they need to diagnose confidently in a single test.
The Senior Biostatistician will have responsibility for planning, directing and coordinating all clinical research statistical development efforts as well as all data management activities utilizing iRhythm products and services.
- – Must have the ability to convert business, scientific and engineering concepts into clear mathematical/statistical concepts and back again for implementation.
- – Must be able to express statistical ideas and concepts in a way that is understandable to non-statisticians.
- – The ability to compose technical reports on a frequent basis.
- – Must be able to work cross-functionally in design, analysis and reporting of US clinical trial studies, including decision impact studies, patient registries, and investigator-sponsored trials.
- – Must support the development of study protocols and drive development and implementation of analysis plans.
Pay Rate / Salary: Competitive with the current market
Skills / Education Requirements:
- – A minimum of a Bachelor’s Degree in Statistics, or Biostatistics. A Masters’ Degree or PhD is desirable.
- – Eight plus years of biostatistics experience, preferably in medical devices.
- – Clinical trial design and clinical trial methodology experience is required.
- – Knowledge of statistics used in clinical trials and associated FDA and industry guidelines.
- – Comfortable interacting and communicating within a matrix environment internally and with different roles externally, in a variety of settings.
- – Knowledge of statistical software such as SAS, Excel, Minitab, or equivalent is a must.
- – Ability to travel approximately 10% of the time.
- – Experience leading functional teams and having direct reports is preferred.
- – Excellent oral and written communications skills with experience composing technical reports.
- – SAS
- – R Programming a plus
- – Minitab
- – Data Management experience – This is a Hybrid role
- – Direct People Management experience and experience leading teams and projects in a matrix function or as a direct manager
- – Medical Device , FDA expertise and understanding of 510K , Filing process
- – Study Protocol Development support experience
- – Experience operating as a lead.
- – Project Management skills.
- – Data Management Experience is IMPORTANT.
- – Protocol Development.
Date Posted: 09/15/2020