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Principal Statistician - Europe home based or office based

JR062558

About the role

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Principal Biostatistician
ICON is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. We specialize in the strategic development, management and analysis of programs that support Clinical Development - from compound selection to Phase I-IV clinical studies.
Position Summary
This position 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. Role could be based at our North Wales office or Home based.
Responsibilities:
  • 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.

Key Requirements:
  • 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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