Senior Statistical Programmer PK/PD

As a Senior Statistical Programmer PK/PD, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities:

1. Planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project.
2. Providing input to authority required documents for the trial and non-trial activities.
3. Ensuring that clinical trial and non-trial tasks are aligned with the project specifications.
4. Responsibility for continuous development of own skills and to contribute to the development of Biostatistics.
5. Providing programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan.
6. Ensuring that mock TFLs are created and reviewed by stakeholders.
7. Making AdaM programming according to industry standard and NN specifications.
8. Ensuring that programming, also by co-workers and functional suppliers, is done according to specifications.
9. Ensuring that the inspection readiness documentation is updated at all times during the trial life cycle.

Required skills and experience:

1. 5+ years of statistical programming.
2. Extensive experience with PK/PD - mandatory.
3. Extensive experience with programming in e.g. R.
4. Experience with reporting clinical trials, including statistical data handling, analysis and reporting.
5. Experience with review and documentation of programs.
6. Good knowledge of drug development.
7. Experience with clinical database technologies, data models and advanced programming.
8. Experience with collaboration across professional and regional borders.
9. Regular experience with communication and presentations.
10. In-depth knowledge of computer systems and IT.
11. Good knowledge of GxP and guidelines within drug development.

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.

Benefits examples include:

1. Various annual leave entitlements.
2. A range of health insurance offerings to suit you and your family's needs.
3. Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
4. 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.
5. Life assurance.
6. 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.