Senior Director, Biostatistics Consulting

Reposted 23 Days Ago
Be an Early Applicant
2 Locations
In-Office
Senior level
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Lead the biostatistics consulting practice by providing statistical guidance, overseeing clinical trial design, and managing cross-functional teams for regulatory compliance and innovative solutions.
Summary Generated by Built In
Senior Director, Biostatistical Consulting

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.


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.

#LI-CL1


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

Skills Required

  • Advanced degree in biostatistics, statistics, or related field
  • Significant experience in biostatistics consulting and clinical trial support
  • Extensive experience in designing and analysing clinical trials
  • Deep understanding of regulatory requirements and statistical methodologies
  • Proven track record of leading and managing biostatistics teams
  • Excellent problem-solving skills for complex statistical issues
  • Proven track record of authoring the statistical sections of regulatory submissions
  • Outstanding communication, interpersonal, and leadership skills

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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