Overview

Job Title – Senior Biostatistician
Location – Remote (Work from Home)

Duration: Long Term

Must-Have: Bachelor’s degree in Biostatistics, or Statistics and 4 years of statistics experience (e.g., statistical/biostatistics analysis) in the healthcare industry or advanced degree in Biostatistics, or Statistics with a minimum of 2 years of statistics experience (e.g., statistical/biostatistics analysis) in the healthcare industry
Job Description:
CVG
Cardiac and Vascular Group (CVG)
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. This group includes Aortic, Peripheral, and Venous (APV), Cardiac Rhythm and Heart Failure (CRHF), Atrial Fibrillation (AF) Solutions, and Coronary and Structural Heart products.
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.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.

  • Applies statistical knowledge and experience to the design of clinical studies, ensuring that study objectives can be met. This requires calculation of sample size and power, as well as possible determination of appropriate design assumptions.
  • In development-phase projects, prepares the statistical component of protocols which meet project objectives, health authority 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 and validity, and works with study team to prevent, track, and manage potential problems.
  • 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.
  • May partner in trial design and in establishing standards for clinical conduct, and the collection, management and/or reporting of data.
  • Writes the statistical analysis plan for the study, if required.
  • Provides specifications and directions to the clinicians/statistical programmers.
  • Supports the regulatory review and approval of the experimental therapies.
  • Interprets statistical and clinical findings, and ensures that regulatory submissions, reports, and manripts accurately reflect the data collected.
  • Writes Results and Methods sections of clinical reports, abstracts and manripts as needed.
  • Consults with other (e.g. non-clinical) staff on statistical and analysis issues.
  • Attends and contributes to project and department meetings.

Must-Have (Minimum Requirements):
To be considered for this role, the minimum requirements must be evident on your resume.
Nice to Have (Preferred Qualifications):

  • Advanced degree in math or statistics
  • Experience as a Biostatistician at Medtronic or for a medical device or healthcare company
  • Extensive SAS or R programming experience
  • Experience working with large data sets
  • Demonstrated ability to communicate technical content to non-statisticians (written and verbal)
  • Experience in Good Clinical Practice (P) and/or regulatory compliance guidelines for clinical trials and medical devices (e.g. ISO, MDD/MDR, CFR)
  • Experience in experimental design
  • Understanding of statistics and statistical methods

Thanks & Regards,
Nitin Parijaat

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