QED Pharmaceutical Services
Quality and Ethics in Data
Biostatistician / Sr. Biostatistician

The primary function of the Biostatistician / Senior Biostatistician is to develop, prepare, facilitate, and maintain timely development/distribution of statistical analyses, tabulations, graphics, and listings of clinical trial data, summaries, and Clinical Study Reports (CSRs). Also, to recommend statistical analysis methodology and perform statistical programming for clinical study data.

Job Responsibilities
  • Develop/Implement/Document

    • Sections of Protocols and reports
    • Statistical analysis plan
    • Shells for tables, figures and listings (including SAS macro)
  • Supervise /Provide technical guidance/Mentoring for statisticians to manage and /or

    • Perform study related statistical activities
    • Perform planned/adhoc statistical analysis
  • Write/Review/Approve

    • Specifications for creating analysis datasets from raw datasets.
    • Statistical sections of final integrated reports that are accurate, logical, clear, concise, thorough and objective.
    • Edit checks and protocol deviation specifications.
    • Results presented in tables, figures and listings.
    • Conclusions for reports, labeling and publications.
    • SAS output and data sets.
    • Programmes for submission to regulatory agencies.
  • Assess data integrity and validity of data
  • Prepare/Apply/Determine

    • Study analysis plan
    • Appropriate statistical methodology and data presentation in order to communicate results to intended audience.
  • Participate in the standardization of

    • Inputs for Case Report Forms and data edit checks
    • Database development and data presentations
    • Software applications
    • Statistical methodology
  • Ensure the accuracy of clinical trial randomizations/statistics/ interpretations in the final result Contribute to

    • Individual development, training, knowledge and expertise.
    • Project planning policies, guidelines and tools.
  • Represent QED to the company and outside collaborative partners to convey QED's corporate mission statement.

  • Job duties require the minimum of a Masters Degree (PhD preferred) in Statistics (or equivalent degree, knowledge, and/or expertise)
  • 4 years' previous experience as a project statistician, preferably in a pharmaceutical, biotechnology or CRO environment, performing planning and implementation of clinical trial data analysis.
  • Must also possess an in-depth knowledge and expertise in statistics and its applications, to clinical trials in at least one therapeutic area, solid knowledge of drug development process and guidelines, and background medical knowledge, preferably in relation to the specific therapeutic area.
  • This position must also have a good working knowledge of statistical software packages (e.g. SAS) and the ability to understand/follow Biometrics SOPs.