Principal Biostatistician
About the role
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- 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.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
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