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Vyaire Medical Biostatistician in Boston, Massachusetts

Biostatistician

About US

At Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference.

To learn more, visit our website: www.vyaire.com

Watch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be

About this role

Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.

We have an exciting opportunity for a Biostatistician with demonstrated expertise in clinical study design and analysis, who specializes in statistical methodologies used to support analytical and clinical validation of medical technology. Working in collaboration with scientists and physicians, you will provide advanced statistical and analytical expertise to Vyaire. You will use your knowledge of clinical study design and biostatistics to provides technical leadership, knowledge, experience and expertise by planning, conducting and supervising clinical development and evidence management projects. You will contribute to the clinical development strategy and ensure statistical integrity, optimal study designs and data and evidence needs are reflected and fulfilled within that strategy. To achieve Vyaire’s objectives, you provide out-of-the-box thinking to develop innovative clinical study designs, quantitative decision making and the incorporation of evidence from disparate sources of big data. Critical deliverables include the design and formulation of statistical methodologies and input that ensure quality and consistency of key data deliverables across studies. You will analyze data and prepare and review study protocols, statistical analysis plans, interim study reports, manuscripts, abstracts and other technical documents and procedures pertaining to statistical methods.

Essential Functions:

  • Be an integral member of product development team responsible for supporting claims development, and data management in clinical studies.

  • Possess data management expertise and advanced knowledge in biostatistical concepts and practical application of such concepts to the assessment of medical device technology.

  • Serve as a subject matter expert in biostatistics, epidemiology, data mining, data analytics, and data management.

  • Provide study design and biostatistical guidance to Offering Management, Marketing and Development teams.

  • Provide functional excellence in the areas of statistics, data analysis and data processing for the department.

  • Apply extensive fundamental and specialized knowledge to the development of clinical protocols for device validation, respond to FDA questions, implementing new approaches to automated data processing for clinical trials.

  • Propose new ideas and recommend implementation plans leading to enhanced efficiencies and faster review and analysis of data.

  • Provide statistical input and advice to clinical teams for the design of studies and sample size/power estimations, including the design, writing and review of study protocols, development of statistical analysis plans and development of analyses requiring advanced statistical methodologies.

  • Design and lead the preparation of statistical components of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards.

  • Lead the analysis, evaluation and planning for methods of approach, and organizes means to achieve the solution to highly complex problems.

  • Interpret and evaluate statistical data and results of the most complex investigations and develop appropriate recommendations.

  • Lead the development of reports, charts, graphs, and other documents which support claims recommendations.

  • Lead building the data and evidence for Vyaire offerings.

  • Support develop the standards for clinical conduct, data collection, management and/or reporting.

  • Provide clear and regular technical and administrative input to professional, technical and administrative personnel assigned to a project.

  • Recognize and address issues which may impact the statistical integrity of the evidence development program or recognition of datasets for which different statistical tools may add value.

Qualifications:

  • PhD or MS degree with a minimum of 5 years of experience. Experience with clinical decision support systems and/or software as a medical device is critical.

  • Demonstrated experience of applying statistical methods in biomedical research, pharmaceutical, medical device or CRO experience is required.

  • Good knowledge of ICH GCP guidelines, FDA regulations and demonstrated experience with pharma and/or medical device clinical trials and FDA/NDA submissions is required.

  • Experience with study design methodology such as adaptive design or pragmatic clinical trials, state-of-the-art modeling approaches, incorporation of real word evidence or experience analyzing big data.

  • Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solutions to novel problems.

  • Sound knowledge of statistical methodologies such as analysis of variance, regression, experimental designs, contingency tables.

  • Expertise with SAS and R.

  • Ability to work independently and in project teams.

  • Excellent communication skills (written and spoken).

  • Required Technical and Professional Expertise

  • At least 5 years of work experience in a Healthcare medical device or Life sciences pharmaceutical regulated process mature environment

  • Preferred Tech and Prof Experience

  • At least 7 years of work experience in a Healthcare medical device or Life sciences pharmaceutical regulated process mature environment

Atlanta, GA, Boston, MA, Charlotte, North Carolina, Dallas, TX, Houston, TX, Irvine, CA, Madison, WI, Mettawa, IL, Milwaukee, WI, Minneapolis, MN, Orlando, FL

Full time

We aspire to a “higher calling” , aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices.

Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories.

We are transforming the future of respiratory care; explore how you can be a part of it.

We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day.

One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.

To learn about our terms of use, please review Terms & Conditions (http://www.vyaire.com/terms-of-use) . Also, provided here is a link to our Privacy Policy (http://www.vyaire.com/privacy-policy)

One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person's race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.

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