Principal Biostatistician

This is an exciting opportunity to work on our high impact and pioneering Vaccines program. Join ICON and be part of ground breaking Vaccines research!

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.

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:

• Prior vaccines experience is preferred, also considered would be Oncology or Rare disease therapeutic area expertise

• M.S. degree in statistics, biostatistics, or related field with minimum of 9 years of relevant experience
• 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.

Benefits of Working in ICON:

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.
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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