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.
- 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.
- 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