Principal Biostatistician

hace 1 semana

Madrid, España Icon Clinical Plc A tiempo completo

.At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.Principal Biostatistician - EMEA (remote or office working)Position SummaryThis 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.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, 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

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