Study Lead Biostatistician

Study Lead Biostatistician

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Principal Biostatistician at ICON, you will design and analyze clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. This position is sitting within the Biosimilars group.

What You Will Do:

• Strong ability to apply statistics in the analysis of clinical trials
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis. This could be to internal audiences (study/product team) OR at external meetings such as investigator meetings, steering committee meetings, ad board meetings or regulatory meetings
• Excellent oral and written English communication skills
• Authored a protocol, DRT/DMC charter, SAP, CSR, or Research Project Plan (RPP)
• Strong knowledge of current CDISC standards for ADaMs
• Strong fundamentals of Project Planning and Project Management
• Demonstrated ability to immediately dive into detailed and/or complex projects
• Strong SAS programming skills in applying statistical procedures based on complex study designs
• Perform all duties and responsibilities associated with the Study Supporting Statistician role
• Oversee the work performed by multiple Study Supporting Statisticians
• Review work performed by Study Supporting Statistician and provide guidance to meet the study and project requirements
• Attend Clinical Study Team (CST) meetings and provide all required statistical input related to strategy and operations of the clinical study
• Plan and execute statistical contributions to Study Outlines, protocols, randomization specifications, Statistical Analysis Plans (SAPs), Table, Listing and Graph ( TLG) shells, Submission Data File (SDF) specifications, other key- study related documentation, protocol deviations, Data Quality Review (DQR), Flash Memos, Clinical Study Reports (CSRs), clinical publications, product plans (e.g. Global Development Plan), Clinical Summary of Safety (CSSs), Clinical Summary of Efficacy (CSEs), Clinical Overviews (COs), regulatory documents, reimbursement documents and other communications
• Assist in resource planning for assigned projects
• Be familiar with all Company’s policies, SOPs and other controlled documents related to all study activities performed
• Be familiar with statistical policy and strategy at Amgen
• Assist with study and systems audits conducted by Company GCA and external bodies
• Stay abreast of latest developments in the field of statistics in drug development

Your Profile:

• Master’s degree in Statistics/Biostatistics or other subject with high statistical content with 6 years of post-graduate statistical experience in the pharmaceutical industry or medical research OR Doctoral degree in Statistics/Biostatistics or other subject with high statistical content with 3 years of post-graduate statistical experience in the pharmaceutical industry or medical research
• Strong skill in communicating statistical information clearly and concisely (written and oral)
• Strong understanding of statistical concepts related to the design and conduct of clinical studies

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

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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