Study Lead Biostatistician
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply