Principal Biostatistician at ICON plc

Overview of the role:

The Principal Biostatistician will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies.

• Biostatistical 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 (SAP) 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

To be successful, you will need:

• M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
• 8+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
• Excellent verbal and written communication skills
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
• Oncology experience is required for this role
• Prior experience interacting with sponsor/clients
• Experience leading Phase II and/or Phase III studies