Position Overview

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. Ensure all the data analysis activities are conducted in accordance with regulatory and company standards.Job duties:
  • Provide technical/statistical leadership and strategic input to clinical projects in collaboration of cross-functional teams.
  • Contribute to the development and documentation of clinical study protocols and Case Report Forms (CRFs) and have the primary responsibility for developing the statistical section of the review and assessment of protocol deviations to the extent that they affect statistical analyses.
  • 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.
  • Generate statistical summary tables, graphs, and reports using SAS for regulatory submissions, conference presentations, and/or marketing publications.
  • Provide consultation to clinical and regulatory project teams on any statistical issues related to trial conduct.
  • Support Medical Affairs with literature reviews and related activities.
  • Contribute to peer-reviewed articles independently, in coordination with the lead author/physician.
  • Complete meta-analyses of published clinical data to support medical affairs, regulatory and marketing objectives.
  • Institute and perform complex statistical techniques to review and analyze clinical data; provide defense for and justification of statistical hypothesis, objectives, and designs.
  • 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.
  • Responsible for the development and review of standard operating procedures for the analysis of clinical study data.
  • Provide statistical support to Regulatory Affairs, Quality Assurance, product development, Scientific and Medical Affairs and other areas of the company as directed. May assist in preparing materials for presentation at professional meetings.
  • Stay current with statistical methodology in clinical trial design and analysis.
  • Domestic/international travel required, up to 10%.
  • Perform additional duties and responsibilities as required.

    1. Ph.D. in biostatistics or statistics.
    2. A minimum of five (5) years of statistical methods experience within the pharmaceutical, medical device, or biotechnology industry.
    3. A minimum of one (1) year of supervisory or management responsibility.
    4. Excellent written and verbal communication skills.
    5. Proficient with Microsoft Access, Excel, Word, PowerPoint, SharePoint, Visio, and Project.
    Desired Qualifications
    1. Proficient in SAS. Familiarity with other statistical packages for handling smaller datasets and power analyses.
    2. In-depth understanding of descriptive statistics, hypothesis testing, non-parametric, and multivariate statistical tests.
    3. Experience with Bayesian statistics, adaptive design, and other innovative statistical methodologies. Knowledge of industry standards and best practices in data management and applicable country regulations (US FDA, ISO, ICH, CDISC).
    4. Knowledge of US law, regulations, and FDA guidance covering good clinical practice (GCP).
    5. Knowledge of meta-analyses and simulation techniques.
    6. Experience with Data Management Systems such as Oracle Clinical.
    7. Knowledge of Bayesian statistics.
    8. Experience with the UNIX operating as well as with other statistical software including S-plus/R.
    9. Ability to handle multiple projects, attention to detail, and demonstrated problem solving and judgment skills.