Senior Biostatistician (Focused on Data Analysis Standards area)

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

In this role, you will be responsible for developing and maintaining standard statistical requirements in data analysis tools and templates, compliant with industry standards and health authority regulations. Standard statistical requirements are aligned with therapeutic area/disease area needs as well as study design considerations.
Examples of standard statistical requirements include:

• Standard text, definitions, and analysis requirements that are included in the Protocol and Statistical Analysis Plan
• Standard tables, listings, and graph mock displays along with detailed analysis requirements and standard analysis rules included in the Data Presentation Specifications

What you will be doing:

• Provide statistical support to clinical studies or projects as assigned.
• Participate in the development of study protocols including study design & sample size calculations, reviewing CRFs & data review guidelines.
• Develop statistical analysis plans including analysis dataset & TLG specifications.
• Perform statistical analyses, interpret statistical results, and help prepare clinical study reports including integrated summaries for submissions.

You have:

• Master's or PhD Degree in Statistics or related field
• Minimum of 3 years for PhD and 5 years for Masters
• Proficiency in SAS or R
• Good written, oral, and interpersonal communication skills
• Specific for CDSA - Data Analysis Standards focus area:
  o Working knowledge of relevant regulatory requirements related to analysis and reporting (e.g., GCP, ICH) and of industry standards (e.g., ADaM) is required.
  o Relevant operational experience in analysis standards is preferred.

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, 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

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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.