Current jobs related to Senior Biostatistician - Perth, Western Australia - Pharmiweb

At ICON, we're committed to advancing and improving patients' lives through clinical development. As a Principal Biostatistician, you'll play a critical role in leading our Biostatistics and Programming activities for a program of studies of moderate complexity and/or of high value with high impact.

• Lead Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.
• Provide biostatistical input into the design of the program, including study design, sample size calculations, and patient randomization schemes.
• Review project database structures, edit checks, and data management coding conventions.
• Prepare statistical analysis plans, including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports.
• Conduct statistical analysis, interpret data, and report results.
• Write the statistical methods sections of integrated study reports and review draft integrated study reports.
• Support responses to regulatory questions on the design of the program and any labelling claims following submission.
• Participate in presentations at client and investigator meetings.
• Prepare biostatistics input to ICON research proposals and participate in proposal defense meetings and make presentations at marketing meetings with prospective clients.
• Ongoing coaching and mentorship of team members.

• M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience (at least 8 of which must be in the pharmaceutical industry); or Ph.D. in statistics, biostatistics, or related field with minimum of 7 years of relevant experience (at least 6 of which must be in the pharmaceutical industry).
• Experience with oncology is required.
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas.
• Excellent verbal and written communication skills as well as interpersonal and project management skills.
• Excellent knowledge of a wide variety of principles, theories, and concepts in statistics and experimental design; must be able to apply them to the development and analysis of clinical trials.
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics, and statistical software packages, including SAS.
• Experience leading a regulatory submission.
• Must be able to translate clients' needs into statistical practice and educate clients in the use of statistics.

We offer a competitive salary package, annual bonuses, and a range of health-related benefits to employees and their families. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. We're an equal opportunity and inclusive employer, committed to providing a workplace free of discrimination and harassment. If you need a reasonable accommodation for any part of the application process, please let us know.