Valeant Pharmaceuticals

Sr. Biostatistician

US-WA-Seattle
Job ID
9284
Category
R&D - Regulatory Affairs
Pos. Type
Full Time

Overview

The Senior Biostatistician applies statistical methodologies to clinical and research datasets; assists in protocol design; develops statistical analysis plans; and drafts presentations of statistical findings and methods

Responsibilities

• Contributing to the development of study protocols, in particular, the statistically-related sections (e.g. sample size calculations, statistical methodology, and statistical analyses).
• Identifying the most appropriate analytical models/methods for clinical studies, and conducting research on statistical methodology, as needed, to accomplish this.
• Participate in developing detailed statistical analysis plans; independently assess the appropriate statistical methodology for data analysis.
• Ensure the scientific integrity of the statistical methodologies applied in and finding reported in clinical trials.
• Participate in database design meetings to ensure that data are free of bias, contain maximum information (minimum variance), and satisfy analytical requirements.
• Analyzing data and interpret results from studies to meet objectives of the study protocol; independently apply and implement basic and complex techniques to these analyses.
• Preparing oral and written reports to effectively communicate results of clinical trials to the project team, senior management, regulatory agencies and/or individual investigators.
• Communicating effectively with regulatory agencies, in meetings and in written material (e.g. briefing documents) the statistical methodologies, analyses, and results of clinical studies.

Qualifications

• PhD/MS degree in Statistics, Biostatistics, or related field and at least 5 years of relevant experience in the pharmaceutical/biotech industry.
• High level of personal motivation and the ability to work independently.
• Ability to provide cross functional support within Clinical and Regulatory Affairs and other departments, as needed.

• Office environment consisting of computer workstations within a cubical setting

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