ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

ICON has an exciting opportunity for aPrincipal Biostatisticianto join our team.

Locations:

• Europe (home-based OR office-based)
• United Kingdom (home-based OR office-based)
• South Africa (home-based OR office-based)

Overview of the role:

The Principal Biostatistician 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.

• Biostatistical 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 (SAP) 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

To be successful, you will need:

• M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
• 9+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
• Excellent verbal and written communication skills
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
• Prior experience interacting with sponsor/clients
• Experience leading Phase II and/or Phase III studies
• Oncology experience is preferred, but not required

Benefits of Working in ICON:

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.

Are you a current ICON Employee? Please click here to apply: link