Senior Biostatistician I (Client dedicated)

Pharmaceutical Research Associates, Inc; United Kingdom; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading clinical research organization is seeking a Principal Biostatistician to provide strategic statistical leadership in oncology clinical trials. Ideal candidates should hold an MSc or PhD in Biostatistics or a related field with at least 5 years experience. This role involves cross-functional collaboration and oversight of statistical deliverables, ensuring scientific rigor. Competitive benefits are offered, promoting a culture of diversity and inclusion.

Benefits

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Life assurance

Flexible optional benefits

Qualifications

• Minimum 5 years of experience in similar role.
• Expertise in developing and validating SDTM and ADaM datasets.
• Experience with regulatory submissions like NDA and BLA.

Responsibilities

• Provide strategic statistical leadership for complex oncology clinical trials.
• Oversee quality and accuracy of statistical deliverables.
• Lead collaboration across functions including regulatory teams.

Skills

Oncology clinical trials

Statistical leadership

CDISC standards

Statistical methodology

Clear communication

Education

Advanced degree (MSc or PhD) in Biostatistics or Statistics

Job description

Overview

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

Responsibilities

What you will be doing:

• Provide strategic statistical leadership for the design, analysis, and interpretation of complex oncology clinical trials, ensuring scientific rigor and regulatory compliance.
• Oversee the quality and accuracy of statistical deliverables, including comprehensive review and QC of SDTM datasets, analysis outputs, and submission documentation.
• Drive the consistent implementation of CDISC standards (SDTM, ADaM) across programs, ensuring alignment with internal and regulatory expectations.
• Lead cross-functional collaboration with clinical development, programming, data management, and regulatory teams to align statistical strategies with program objectives.
• Effectively communicate high-level statistical concepts and analytical insights to clinical and non-statistical stakeholders, influencing decision-making at a strategic level.

Qualifications

You are:

• Holder of an advanced degree (MSc or PhD) in Biostatistics, Statistics, or a closely related discipline, with a solid foundation in clinical research methodology.
• Experienced in oncology clinical trials, with a strong track record across multiple phases (I–III) and proven contributions to trial design and regulatory interactions - minimum 5 years of work experience in similar role.
• Expert in CDISC standards, with extensive hands-on experience in developing and validating SDTM and ADaM datasets.
• Capable of working autonomously and providing statistical leadership, with a proactive and solution-oriented mindset.
• A clear and confident communicator, able to present complex statistical topics to varied audiences in English, both verbally and in writing.
• Experience with haematologic oncology indications (e.g., multiple myeloma, leukemia, lymphoma) and their unique statistical considerations.
• Strong understanding of advanced statistical methodologies and innovative trial designs applicable to oncology drug development.
• Prior involvement in regulatory submissions (e.g., NDA, BLA) and direct interactions with health authorities such as the FDA and EMA.
• Experience working in large-scale, international clinical trials with cross-regional coordination.

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-accommodationsInterested 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.