Principal Statistician - Europe home based or office based
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, with relevant experience in the pharmaceutical industry or Ph.D. in statistics, biostatistics
- 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.
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Reasonable AccomodationsDay in the life
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