Principal Biostatistician

Key Skills

Agile methodologies, Data Analysis, Data management, Database, Design, Effective communication skills, Mathematical modeling, MATLAB Programming, Planning and organization, SAP

Job Description

Principal Biostatistician - Oncology

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.

We are expanding our global Biostatistics and Programming team across Europe and are currently looking for experienced people to join this successful and evolving group, which forms part of a brand new operational center of excellence; ICON Operational Delivery (IOD).

We have an exciting opportunity for a Principal Biostatistician to be a critical part of the development of cutting-edge science to help our clients create transformative medical technologies for patients. Lead, plan, monitor, organize, and review activities of a team of biostatisticians and programmers working on a program of studies. Provide protocol input, sample size calculations, patient randomization schemes, and statistical aspects of case report form design.

Come and join his thriving team currently made up of over 600 professionals based across 30 countries, all working together to help save and improve patients’ lives.

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)
• 8+ 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
• Oncology experience is required for this role
• Prior experience interacting with sponsor/clients
• Experience leading Phase II and/or Phase III studies

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

ICON, including subsidiaries, 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.