Principal Biostatistician

We are seeking a highly skilled Principal Biostatistician to lead our biostatistics and programming activities for a program of studies of moderate complexity and/or of high value with high impact for the organization. The successful candidate will be 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, and to required quality.

• 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.
• Perform 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 labeling 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 a 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 a 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, and the ability 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.
• Ability 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. We also provide a range of flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and life assurance.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.