Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant procurement services to the transplant community.
As Manager of the statistical team, you will lead and support all statistical and programming activities. This role will work with Scientific and Medical Affairs management, responsible for oversight of the design, validation, analysis and interpretation of clinical data from multiple registries in support of product development and business objectives. The position is based out of our Waltham office in the greater Boston area. Hybrid work environment, at least 3 days in-office expected.
Responsibilities
- Lead statistical analysis and programming support within multiple studies to ensure timely and high-quality deliverables in assigned projects and areas.
- Manage individuals, resources, timelines and priorities for statistical projects.
- Use advanced statistical methods to validate and analyze data.
- Write efficient code for processing data utilizing tools such as EXCEL and R.
- Create processes for validating quality and accuracy of data.
- Perform statistical programming and data analysis, as well as database cleaning, verification and validation, and quality review of statistical analyses.
- Work with medical affairs staff and clinical investigators to determine appropriate study and protocol design.
- Act as a technical resource to provide advice on complex programming tasks, standards, and processes.
- Responsible for statistical analysis plans (SAP) and development/validation of tables/listings/figures for statistical reports.
- Support statistical methods and results sections for presentations, reports, regulatory documents/filings and peer-reviewed manuscripts.
- Collaborate on development of case report forms and clinical databases to ensure quality data collection
- May be involved in analyses of ‘big data' for market assessments, as well as from public sources (such as UNOS).
- Organized, self-starter; problem solving and innovative skills with an ability to work in a fast-paced environment with a “roll up your sleeves” attitude.
- Ability to influence others, mentor, and coach junior statisticians to achieve results and foster professional development.
- Excellent oral and written communication, and interpersonal skills necessary to interact with a wide range of individuals and cross-functional stakeholders.
Qualifications
- At least 5-10 years of experience in a biomedical life science or medical device company, programming using R statistical software, including experience managing a team.
- Comprehensive knowledge of statistical methods
- Prior healthcare or medical device industry experience
- Proficiency in R programming skills in a clinical data environment with excellent analytical skills. Knowledge of other programming languages such as SAS, Python etc. is a plus.
- Prior experience working with research and/or healthcare data.
- Bachelor's degree in biostatistics, statistics, epidemiology or similar area of study, required.
- Master's degree or higher in biostatistics or relevant area of study preferred.
- Proficient in Microsoft Office Suite.
- Transplant surgery /medical knowledge is a plus.
- Experience or knowledge of FDA regulations or submissions is a plus.