Senior Biostatistician I

Principal Biostatistician

• Accountable for leading Biostatistics and Programming activities for a program of studies of high complexity and/or of high value with high impact.
• Bio statistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
• Review project database structures, edit checks and data management coding conventions
• Preparation of statistical analysis plans including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
• Statistical analysis, Interpretation of data and reporting of results.
• Writing of the statistical methods sections of integrated study reports.  Reviews draft integrated study reports.
• Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
• Participates in presentations at client and investigator meetings.
• Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings and makes presentations at marketing meetings with prospective client. 
• 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 are a must.
• Experience leading a regulatory submission
• Must be able to translate clients’ needs into statistical practice and educate clients in the use of statistics.