Biostatistics Manager

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 a Biostatistics Manager to join our company.

The Biostatistics department is responsible for the statistical aspects of clinical trials including experimental design, statistical programming/analysis and reporting. This position manages the activities of a team of Statisticians with an aim of meeting departmental goals. The Biostatistics Manager will be responsible for the technical development of Statisticians and provide support and drive departmental initiatives. The role also includes functioning at a senior technical level on projects as required.

Locations:

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

Overview of the role:

• Serves as a statistical consultant to other biostatisticians within a number of ICON offices.
• Oversees statistical input to study design and analysis.
• Works with the Associate Director/Director of local ICON offices to ensure that appropriate analysis procedures are used and that study reports accurately describe statistical methods and results of analyses.
• Oversees statistical activities that support ICON's interactions with clients and regulatory agencies.
• Provides input to ICON and client clinical and regulatory departments on statistical issues relating to client regulatory submissions.
• Responds to statistical questions raised by regulatory agencies and assists clients with statistical aspects of regulatory agency negotiations.
• Reviews and approves statistical methods sections of study protocols, statistical analysis plans, statistical analyses, and statistical input to reports.
• Works with the Associate Directors/Directors/Senior Directors of local ICON offices to establish and maintain effective training and continuing education programs for ICON biostatistics staff.
• Collaborates with Biostatistics Departments in other locations within ICON to develop and maintain standard operating procedures (SOPs) and study specific procedures (SSPs)
• Prepares and approves research proposals and budgets to provide statistical consulting and to conduct statistical analyses for clients in the pharmaceutical, biotechnology, computer, and manufacturing industries. As needed, participates in proposal defense meetings and makes presentations at marketing meetings with prospective clients.
• In conjunction with members of the Statistical Programming Department, documents analysis and programming work to ensure a complete audit trail for assigned projects. Participates in the setting of document standards.
• Functions as a Senior Biostatistician, Project Director on projects as needed.
• Performs additional duties as assigned

To be successful, you will need:

• M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
• 10+ years of relevant experience with M.S. OR 8+ 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
• Experience leading a team is necessary
• Oncology experience is preferred, but not required

Benefits of Working in ICON:

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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