Senior Biostatistician (Focused on Data Analysis Standards area)

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Senior Biostatistician (Focused on Data Analysis Standards area)

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

In this role you will be responsible to develop and maintain standard statistical requirements in data analysis tools and templates, compliant to 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

• 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, interprets statistical results, and helps prepare clinical study reports including integrated summaries for submissions.

• 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 (eg, GCP, ICH) and of industry standards (eg, ADaM) is required
  o Relevant operational experience in analysis standards is preferred.

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 designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

• 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

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. 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 through the form below.

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.