Position Overview

The Biostatistician will lead and drive the application of statistical and research methodological principles for the design, execution and analysis of clinical trials as well as post-market data analysis projects. The Biostatistician will ensure all the data analysis activities are conducted in accordance with regulatory and company standards. Typical duties might include:
  1. Contribute to the development and documentation of clinical study protocols, and have the primary responsibility for developing the statistical section of the protocols.
  2. Develop the statistical analysis plan for all phases of clinical studies to ensure consistency with the protocol and adequacy to meet objectives defined in protocol under limited supervision.
  3. Generate statistical summary tables, graphs and reports using SAS for regulatory submissions, conference presentations, and/or marketing publications.
  4. Provide consultation to clinical and regulatory project teams on any statistical issues related to trial conduct.
  5. Support Medical Affairs with literature reviews and related activities.
  6. Complete meta-analyses of published clinical data to support medical affairs, regulatory and marketing objectives.
  7. Institute and perform complex statistical techniques to review and analyze clinical data; provide defense for and justification of statistical hypothesis, objectives and designs.
  8. Lead and drive the development of data quality standards; develop programs that satisfy the standards where needed; and provide quality control for statistical programs and methodology.
  9. Responsible for the development and review of standard operating procedures for the analysis of clinical study data.
  10. Provide statistical support to Regulatory Affairs, Quality Assurance, product development, Scientific and Medical Affairs and other areas of the company as directed.
  11. May assist in preparing materials for presentation at professional meetings.
    1. Ph.D in Biostatistics or a Master's degree inBiostatistics with five (5) years of statistical methods experience within medical device, biotechnology or pharmaceutical industry.
    2. A minimum of two (2) years of statistical methods experience within the biotechnology or medical device industry.
    3. Knowledge and skills of SAS and PC applications software.
    4. Demonstrated knowledge of industry standards and best practices in data management and applicable country regulations (US FDA, ISO, ICH, CDISC).
    5. Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP).
    6. Working knowledge ofmeta-analyses and simulation techniques.
    7. Experience with Data Management Systems such as Oracle Clinical.
    8. Experience with Microsoft Access, Excel, Word, PowerPoint, SharePoint, Visio and Project.
    Preferred Qualifications
    1. Ability to handle multiple projects and demonstrates problem solving and judgment skills.
    2. Communication, team work and attention to detail.
    3. Knowledge of Bayesian statistics (preferred).
    4. Experience with the UNIX operating as well as with other statistical software including S-plus/R (preferred).