Senior Director, Biostatistics Consulting

Senior Director, Biostatistical Consulting

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.

We are currently seeking a Senior Director, Biostatistics Consulting to join our diverse and dynamic team. As a Senior Director, you will play a pivotal role in leading our biostatistics consulting practice by providing expert guidance on optimal statistical design,  helping with regulatory agency negotiations, and guiding the strategic direction of clinical research programs in collaboration with therapeutic area experts. 

You will contribute to the success of our clients through your expertise in statistical design and interpretation of results, perspective on successful strategies across different therapeutic areas and by providing insight on likely regulatory agency acceptance of your proposed options.

What You Will Be Doing:

• Leading the biostatistics consulting practice, overseeing the development and implementation of statistical strategies and methodologies to support clinical research and regulatory approval.
• Providing expert biostatistical guidance on study design, statistical analysis, and data interpretation to ensure high-quality and scientifically valid results.
• Collaborating with cross-functional teams, including clinical and regulatory affairs, to align biostatistical approaches with study objectives and regulatory requirements.
• Developing and implementing best practices for statistical consulting, ensuring adherence to industry standards and promoting innovative solutions for complex statistical challenges.
• Building and maintaining strong relationships with clients and stakeholders, delivering expert consulting services, and driving strategic growth in the biostatistics practice.
• When required attending sponsor meetings with regulatory authorities.

Your Profile:

• Advanced degree in biostatistics, statistics, or a related field, with significant experience in biostatistics consulting and clinical trial support.
• Extensive experience in designing and analysing clinical trials, with a deep understanding of regulatory requirements and statistical methodologies.
• Working knowledge of the application of Bayesian methodologies in a clinical research environment.
• Proven track record of leading and managing biostatistics teams, with strong expertise in strategic planning and client management .
• Excellent problem-solving skills, with the ability to address complex statistical issues and drive innovative solutions.
• Proven track record of authoring the statistical sections of regulatory submissions and responding to regulatory questions .
• Outstanding communication, interpersonal, and leadership skills, with the ability to present complex statistical concepts clearly and collaborate effectively with stakeholders across the organization.

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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