Principal Biostatistician (Client dedicated)

As a Principal Biostatistician, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Apply sound statistical methodology and generate reproducible, high-quality results through well-organized and error-free analysis programs using R.
• Independently lead complex statistical analyses with minimal oversight.
• Contribute to protocol design, statistical analysis plans (SAPs), data interpretation, and reporting across multiple clinical and/or non-clinical projects.
• Ensure compliance with internal SOPs, work instructions, project documentation standards, and applicable regulatory guidelines.
• Participate in cross-functional project meetings, translating research goals into statistical questions and actionable analysis strategies.
• Conduct exploratory analyses, develop visualizations, and communicate results clearly to stakeholders.
• Maintain thorough project documentation to ensure transparency, reproducibility, and adherence to best practices for data integrity.
• Support timely project delivery through effective time tracking and task management.
• Design and maintain standardized statistical analysis tools and templates aligned with therapeutic area objectives, study designs, and regulatory expectations.
• Develop core statistical content for protocols, SAPs, tables/listings/figures (TLFs), and data presentation specifications.
• Manage version control and formal change processes for statistical standards, ensuring accurate tracking, approval, and dissemination.
• Collaborate with data standards teams and implementation leads to facilitate consistent application of standards across programs.
• Build and maintain strong working relationships with internal and external stakeholders, with the support of Statistics & Decision Sciences leadership.
• Provide expert guidance on statistical standards, data analysis requirements, and regulatory best practices.

You are:

• PhD in Statistics, Biostatistics, or related field with a minimum of 3 years of relevant experience, or Master’s degree with at least 5 years of hands-on experience in a pharmaceutical, biotech, or CRO environment.
• Proficiency in R programming, with the ability to produce clean, reproducible code.
• Strong understanding of industry standards such as CDISC, ADaM, and SDTM.
• Working knowledge of regulatory requirements including ICH, GCP, and other relevant guidance related to statistical analysis and reporting.
• Excellent written, oral, and interpersonal communication skills.
• Demonstrated ability to work independently, prioritize tasks effectively, and manage multiple timelines.
• Operational experience in the development, governance, or implementation of analysis standards is highly desirable.

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 maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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.

https://careers.iconplc.com/reasonable-accommodations

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. #J-18808-Ljbffr