• Designs, plans and executes biostatistical components of plans for research and development projects • Uses sound statistical methodology to conduct studies relating to the life cycle of the product • Prepares the statistical component of protocols which meet project objectives, health authority guidelines, and clinical trial methodology standards • Develops and/or applies statistical theories, methods, and software • Summarizes and interprets data into tabular and graphical formats • Responsible for the statistical component of reports describing studies, outcomes and methods used • Provide specifications and directions to the clinicians/statistical programmers • Supports the regulatory review and approval of the experimental therapies • Partner in trial design and in establishing standards for clinical conduct, data collection, management and/or reporting.