Clinical Research Statistician
- Use advanced statistical methods to validate and analyze data
- Write efficient code for processing data utilizing R statistical software.
- 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
- Manage resources, timelines and priorities for assigned projects
- Work with clinical affairs staff and clinical investigators to determine appropriate study and protocol design
- Provide statistical expertise to clinical affairs staff to ensure that the CRFs and database meet the study design needs
- Responsible for statistical analysis plans (SAP) and development of tables/listings/figures for statistical reports
- Prepare statistical methods and results sections for presentations, reports, and peer-reviewed manuscripts
- Participate in preparing and writing statistical content for 501k and other FDA required reports
- May be involved in analyses of 'big data' for market assessments, as well as from public sources (such as UNOS)
- Organized, self-starter; ability to work in a fast-paced environment with a "roll up your sleeves" attitude
- Ability to work independently and as part of a team
- Excellent oral and written communication, and interpersonal skills necessary to interact with a wide range of individuals and cross-functional stakeholders.
- At least 2-4 years of statistical work experience in a biomedical life science or medical device company, including programming using SAS or R statistical software.
- 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.
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