Latest Vacancies at ICON Plc

The Role:

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

• Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
• Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.

What you need

• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities preferable but not required.
• Fluent Dutch or German language

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

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The Role:

As a member of the Study Start Up Team, you will play an integral role in making sure that physicians at our research sites are prepared to start the trial of investigational, new pharmaceutical and biological products for clinical trials at their local practices.

• Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
• Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.

What you need

• A high school diploma or local equivalent
• Bachelor’s Degree preferably in Life Sciences
• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities preferable but not required.
• Fluent Dutch or German language

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

What you will be doing:

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study protocols.
• Develops Statistical Analysis Plans and/or performs senior quality review of statistical analysis plans
• Review and interpret results from simple to complex clinical studies.
• Provide relevant input in the development and review of CRFs.
• Performs lead review and sets up QC of TFL’s
• Perform critical review of derived datasets specifications and derived datasets (ADaM).
• Presentation of key results
• Contribute to clinical study reports.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Oversee trials outsourced to Contract Research Organizations from a Biostatistics perspective
• Contributes to press releases and scientific papers.

You are:

• Master’s degree in statistics or biostatistics or related subjects
• 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies
• Thorough knowledge of and experience with CDISC standards
• Previous experience in writing of SAP
• Previous experience in creation of analysis for publications
• Previous experience in SAS programming
• Strong communication skills
• Knowledge of ADAM and TFL programming

go to method of application »

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

What you will be doing:

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study protocols.
• Develops Statistical Analysis Plans and/or performs senior quality review of statistical analysis plans
• Review and interpret results from simple to complex clinical studies.
• Provide relevant input in the development and review of CRFs.
• Performs lead review and sets up QC of TFL’s
• Perform critical review of derived datasets specifications and derived datasets (ADaM).
• Presentation of key results
• Contribute to clinical study reports.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Oversee trials outsourced to Contract Research Organizations from a Biostatistics perspective
• Contributes to press releases and scientific papers.

You are:

• PhD in statistics or biostatistics or related subjects and 5+ years of experience as a biostatistician in CRO or Pharmaceutical companies OR Masters degree in statistics or biostatistics or related subjects and 10+ years of experience as a biostatistician in CRO or Pharmaceutical companies
• Thorough knowledge of and experience with CDISC standards
• Thorough knowledge of and experience in Regulatory
• Previous experience in working on Phase 2 and 3 studies
• Previous experience in R programming, ESTIMANDS and adaptive designs
• Previous experience in writing of SAP
• Previous experience in creation of analysis for publications
• Strong Leadership and Communication skills
• Knowledge of ADAM and TFL programming

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As Senior Biostatistician, you will execute diverse statistical tasks supporting the clinical development programs. The tasks mainly focus on guarantying by means of thorough review outstanding statistical quality. You will be involved throughout the full clinical trial process, from study design and protocol writing, over defining the statistical analyses (SAP) to reviewing all study outputs and the corporate social responsibility.

What you will be doing:

• Serve as the responsible biostatistician on clinical trials.
• Contribute to clinical study synopses and protocols.
• Develops Statistical Analysis Plans and/or performs senior quality review of statistical analysis plans
• Review and interpret results from simple to complex clinical studies.
• Provide relevant input in the development and review of CRFs.
• Performs lead review and sets up QC of TFL’s
• Perform critical review of derived datasets specifications and derived datasets (ADaM).
• Contribute to clinical study reports.
• Review simple to complex randomization specifications and dummy randomization schemes.
• Participate in bid defense meetings.
• Contributes to press releases and scientific papers.

You are:

• Master’s degree in statistics or biostatistics required.
• Minimum of 6-8 years of biostatistical experience desired.
• Clinical experience is mandatory
• Exhibit expertise in multiple statistical areas, the drug development process, SAS procedures and good programming practices.
• Thorough knowledge of and experience with CDISC standards is desired.
• Demonstrate ability to plan, supervise, implement and monitor the statistical processes for multiple clinical trials.
• Knowledge of ICH-GCP and other applicable legislation to successfully execute the clinical study.
• Auto-immune and/or oncology clinical study background is a plus.
• Experience in managing vendors is a plus