Job Vacancies at ICON plc

Overview of the Role:

The Principal Statistical Programmer will be responsible for creating, validating, and executing a range of statistical programs and applies extensive domain knowledge in the programming of datasets, tables, figures, and listings for quality and accuracy.

The Principal Statistical Programmer will lead and execute multiple projects in parallel, including ongoing coaching and mentorship of individual team members. In this client-facing role, you will be responsible for leading programming deliverables for complex assignments and building long-term relationships with clients in a partnership role.

Key responsibilities will include:

• Lead and manage the assigned programming team’s deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
• Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed metrics (e.g. KPIs) and quality standards.
• Deliver high quality statistical programming deliverables for all assignments that consistently meets study timelines, quality standards, sponsor and/or contractual requirements.
• Efficient use of SAS, and adherence to SAS programming guidelines.
• Create and validate listing and safety outputs (analysis datasets, tables, figures)
• Create and validate efficacy outputs (analysis datasets, tables, figures)
• Create and validate complex programs (such as project or departmental macros)
• Create analysis dataset specifications (ADaM or client-specific)
• Set-up standard programming directories and start-up utilities.
• Create, document and validate project/study-macros at the table, listing and figure level.
• Liaise effectively with other ICON functions (e.g., PM, DM, MW), as required during the life of the project.

To be successful, you will need:

• 8+ years of experience successfully performing the role of Statistical Programmer, in the clinical research industry
• Experience with leading multiple projects in parallel – including Phase II and/or Phase III studies
• Experience leading oncology studies and knowledge of RECIST is strongly preferred
• Experience with creating and validating analysis datasets (CDISC ADaM standard), and Tables, Listings, and Figures
• Pinnacle 21 experience is strongly preferred
• Expert knowledge of SAS
• Professional leadership skills coupled with exceptional communication skills
• Education: Bachelor’s degree required (Statistics, Mathematics, Computer Science, or related scientific discipline); Master’s degree or PhD preferred

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Role overview:

As a Sr Project Manager you will be expected to contribute towards a culture of business excellence with a focus on quality, scope, timelines adding value to the business and exceeding client expectations. You would be involved at the forefront of innovation and drive delivery using your project leadership expertise. Delivering successful working relationships with clients, cross functional project planning, scheduling and implementation, defining project scope, resource requirements and deliverables, risk mitigation strategies, associated action plan and issue resolution and budget management.

• Delivering successful working relationships with clients, cross functional project planning, scheduling and implementation, defining project scope, resource requirements and deliverables, risk mitigation strategies, associated action plan and issue resolution and budget management
• Work in matrix teams on global international projects and be responsible for the overall coordination, implementation and completion of regional/global cross functional projects
• Provide expert project management input into new business proposals and bid defense meetings

Role requirements:

• Bachelor's Degree in medicine, science or equivalent degree are desirable
• Demonstrable Sr Project Management experience within clinical research is essential
• Demonstrable experience within late phase studies in a CRO environment, needed
• Strong communication, planning, decision-making, negotiation, conflict management and time management skills
• Experience in global/ multi country studies
• Willingness to travel up as needed

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The role:

• The Clinical Trial Manager is responsible for the delivery of all clinical aspects of the study.
• The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrolment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors & cross-functional teams, identifies & mitigates risks that may impact clinical delivery, and provides reporting & metrics on all clinical activities.
• The CTM will also participate in Sponsor, Investigator and bid defense meetings.

You will need:

•  4 year degree or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
•  Subject matter expertise in the designated therapeutic area
•  Prior monitoring experience is preferred
• Ability to travel up to 20%
•  Fluent in local language - both written & verbal

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Overview of the role:

The Principal Biostatistician will be accountable for the leadership of the Biostatistics and Programming activities of a program of studies of moderate complexity and/or of high value with high impact for the organization. Also responsible for planning, monitoring, organizing, and reviewing activities of biostatisticians and programmers working on the assigned program of studies, ensuring individual studies and the overall program of studies and integrated analyses are delivered on time, on budget to required quality. Accountabilities also include maintenance of consistency across studies.

• Biostatistical input into the design of the program, Protocol input such as study design, sample size calculations and patient randomization schemes and Statistical aspects of case report form design
• Review project database structures, edit checks, and data management coding conventions
• Preparation of statistical analysis plans (SAP) including the definition of derived data, and the design of statistical tables, figures, and data listings for clinical summary reports
• Statistical analysis, Interpretation of data and reporting of results
• Writing of the statistical methods sections of integrated study reports; reviews draft integrated study reports
• Supports responses to regulatory questions on the design of the program, and any labelling claims following submission
• Participates in presentations at client and investigator meetings
• Preparation of biostatistics input to ICON research proposals, and participates in proposal defense meetings, and makes presentations at marketing meetings with prospective client

To be successful, you will need:

• M.S. or Ph.D. degree in statistics, biostatistics, or related field (required)
• 8+ years of relevant experience with M.S. OR 7+ years of relevant experience with Ph.D. (with at least 6-8 years of experience in the pharmaceutical industry)
• Excellent verbal and written communication skills
• In-depth knowledge of study designs, and statistical analysis applications in one or more therapeutic areas
• Excellent knowledge of clinical trials methodology, regulatory requirements, statistics and statistical software packages, including SAS are a must
• Oncology experience is required for this role
• Prior experience interacting with sponsor/clients
• Experience leading Phase II and/or Phase III studies

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Overview of the Role:

The Principal Statistical Programmer is responsible for creating, validating, and executing a range of statistical programs and applies extensive domain knowledge in the programming of datasets, tables, figures, and listings for quality and accuracy.

The Principal Statistical Programmer will lead and execute multiple projects in parallel, including ongoing coaching and mentorship of individual team members. In this client-facing role, the Principal Statistical Programmer is responsible for leading programming deliverables for complex assignments. The Principal Statistical Programmer will invest in building long-term relationships with clients in a partnership role.

Key responsibilities will include:

• Lead and manage the assigned programming team’s deliverables at the study and program level to ensure project objectives are met within budget, to agreed timelines and to the highest standard of quality.
• Proactively plan for and implement effective resource planning, task allocation and tracking of workload in accordance with agreed metrics (e.g. KPIs) and quality standards.
• Deliver high quality statistical programming deliverables for all assignments that consistently meets study timelines, quality standards, sponsor and/or contractual requirements.
• Efficient use of SAS, and adherence to SAS programming guidelines.
• Create and validate listing and safety outputs (analysis datasets, tables, figures)
• Create and validate efficacy outputs (analysis datasets, tables, figures)
• Create and validate complex programs (such as project or departmental macros)
• Create analysis dataset specifications (ADaM or client-specific)
• Set-up standard programming directories and start-up utilities.
• Create, document and validate project/study-macros at the table, listing and figure level.
• Liaise effectively with other ICON functions (e.g., PM, DM, MW), as required during the life of the project.

To be successful, you will need:

• 8+ years of experience successfully performing the role of Statistical Programmer, in the clinical research industry
• Experience with leading multiple projects in parallel – including Phase II and/or Phase III studies
• Experience with creating and validating analysis datasets (CDISC ADaM standard), and Tables, Listings, and Figures
• Pinnacle 21 experience is strongly preferred
• Expert knowledge of SAS
• Professional leadership skills coupled with exceptional communication skills
• Education: Bachelor’s degree required (Statistics, Mathematics, Computer Science, or related scientific discipline); Master’s degree or PhD preferred

go to method of application »

Key responsibilities:

• Create, validate, execute, and generate statistical programs consisting of listings, safety and efficacy outputs (analysis datasets, tables, figures)
• Create, review, and finalize analysis dataset specifications
• Create, use, and modify project or department level macros
• Lead team(s) to produce high quality SAS programming outputs for all deliverables
• Serve as a mentor and help to train junior staff
• Provide analysis programming (ADaM/TLF) and ADaM specification development and support for or with your team

To be successful, you will need:

• 5+ years of experience successfully performing the role of Statistical Programmer, in the clinical research industry
• Experience leading Phase II and/or Phase III studies
• Experience creating and validating analysis datasets (CDISC ADaM standard preferred), and Tables, Listings, and Figures (TLF)
• Strong SAS programming experience
• Pinnacle 21 experience is strongly preferred
• Professional leadership skills coupled with exceptional communication skills
• Bachelor’s degree required (Statistics, Mathematics, Computer Science, or related scientific discipline); Master’s degree or PhD preferred

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The Role:

• This is a permanent, home-based position available to hire in multiple EMEA countries
• The Clinical Trial Manager is responsible for the delivery of all clinical aspects of the study.
• The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrolment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors & cross-functional teams, identifies & mitigates risks that may impact clinical delivery, and provides reporting & metrics on all clinical activities.
• The CTM will also participate in Sponsor, Investigator and bid defense meetings.

You will need:

•  Experience in leading Clinical Teams at a Regional or Global level
•  Demonstrated ability to drive the clinical deliverables of interventional studies
•  Knowledge of risk-based monitoring• Subject matter expertise in the designated therapeutic area
•  Prior monitoring experience is preferred
•  Fluent in English
•  4 year degree or equivalent combination of education & experience

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You will be responsible for managing a local clinical team effectively, maximizing resource use to deliver operational, quality, and fiscal targets whilst ensuring employee engagement, retention and growth.

Management of the Clinical team through:

• Development of plans to support growth and career development of assigned Clinical Operations employees as well as manage the delivery of quality performance in line with their job description.
• Ensures staff development and performance feedback are provided through activities such as mentorship and career development
• Communicates team and individual goals and expectations to ensure direct reports understand their responsibilities
• Responsible for managing the performance of staff
• Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed customer expectations.
• May conduct assessment visits with staff as required by SOPs

Responsible for the management of resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual expectations by:

• Reviewing project tasks and timelines and assigning team members
• Schedules and reviews project tasks, provides leadership in the delivery of services to clients
• Provides guidance/insight on aspects of clinical operations, as well as contingency planning, to accommodate projects while identifying potential impacts to the budget
• Leading Clinical Operations employees in the delivery of services to clients
• Ensuring staff fulfill their responsibilities in accordance with policies, procedures, SOPs, ICH-GCPs, and other relevant regulatory requirements
• Liaising with other functional managers to ensure consistency within the company
• Maintaining utilization of all Clinical Operations employees within department goals

Provides leadership and implement Clinical Operations services and productivity improvements to ensure optimal utilization of billable team by:

• Performing metric collection and data analysis to support continuous improvement in policies, procedures, and business process
• Identifying and implementing process improvements through review of clinical operations SOPs, processes;
• Leading task forces to implement process improvement initiatives
• Building teamwork and improving process and productivity by working within and across functional areas
• Be a point of escalation (internal) for resolution of issues and conflicts.
• Evaluates compliance of assigned Clinical Operations employees with systems and processes
• Provides support with proposal development and participates in client presentations and/or bid defense meetings, as required

Requirements

• Undergraduate degree or its international equivalent in clinical, science, or health-related field
• Substantial clinical trials development experience is required
• Experience supervising or managing professional staff in a clinical research environment required
• Has a good knowledge of Clinical Operations processes and systems.
• Understands interrelation of Clinical Operations functions within the department and across the full clinical trial process
• Ability to set expectations and monitor employee performance.
• Strong mentoring and leadership skills
• Ability to identify and hire strong candidates through hiring processes
• Comprehensive knowledge of SOPs, and other policies and processes required by functional managers.

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• As a Clinical Research Associate at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The Role:

• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

You will need:

• 18 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication in Local language and English
• Ability to work to tight deadlines
• Availability to travel
• Oncology experience

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We have an incredible opportunity for an experienced Clinical Data Lead to join the team.

The role:

•  As a member of staff, the employee is encouraged to accept and supply to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
•  Travel (approximately 10%) domestic and international
•  Ensure all work performed is of high quality, aligned with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations
•  Independently prepare all materials and take part in study kick off (internal and external) meeting
•  Read, ensure understanding and adhere to the study's protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study
•  Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the DMPM and Contract analyst
•  Independently compile the change order log and distribute internally as per ICON's change order process
•  Demonstrate an understanding revenue recognition/forecasting process by performing the process monthly
•  Ensure effective implementation of standard metric and status reporting on study
•  Independently perform project planning tasks and develop the project plan and timelines
•  Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors
•  Adhere to ICON/Client SOPs, the Data Management Plan, Working procedures and study specific procedures in the implementation of tasks on the study
•  Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components
•  Independently attend and provide an update for data management services at cross- functional study team meeting both internally and with the sponsor
•  Maintain and track meeting minutes, issues and decisions logs, and critical issues
•  Independently negotiate the time lines and make study level decisions
•  Provide regular study status updates to the DMPM
•  Support the DMPM in the delivery of study specific training to all team members, ensuring that the training is detailed and the documentation filed in the DM Study files
•  Deliver training to cross-functional study team members both internal and external (e.g. training in the study specific electronic CRF for monitors or Site staff at the investigatory meeting)
•  Represent Data Management at internal/external audits and manage findings through resolution both operationally and within the Quality Management System

You will need:

•  A minimum of 5 years clinical data management experience including 3 years' experience as a data management lead or point of contact for day to day activity on studies with key responsibilities for study set-up and close-out tasks as well as leading all aspects of and coordinating tasks delegated to the study team members
•  Experience of at least one of ICON preferred CDMS (e.g. Rave, Inform, Oracle Clinical, OCRDC, UX EDC)
•  Highly computer literate, including strong Microsoft Office skills (Excel, Word, PowerPoint, Project)
•  Excellent communication and interpersonal skills, both verbal and written skills
•  Strong client relationship management skills and the aptitude to develop this further
•  Excellent organizational and planning skills as well as a demonstrated aptitude for project management, and the ability to lead more than one project and prioritize accordingly

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• The Senior Statistical Programmer will provide programming leadership for high complexity studies including effective resource planning, work allocation and progress tracking to ensure project timelines and quality targets are consistently achieved.
• In this client facing role, the Senior Statistical Programmer will be responsible for writing programming specifications and the development/QC of statistical programs and applying extensive domain and therapeutic knowledge in the programming of datasets, tables, figures and listings to ensure quality and accuracy.

What will you be doing?

You will be responsible for completion of the following:

• Develop, review, document and perform validation of SAS programs and macros.
• Support the development of data repositories, pooling multiple studies
• Create standard reports in different output formats
• Automate programming tasks within the SAS environment
• Generate programmed QC checks
• Build utilities in support of other programming tasks
• Design new tools or review existing tools and improve where needed.
• Develop, validate and document programs for ad-hoc analyses.
• Assess the time needed to develop programs and can at least partially self-manage the work.
• Take responsibility to deliver a support in time in function of stakeholders needs.

What do you need to have?

A strong communicator with a proactive nature and a willingness to work as part of a team! Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support.

To enable success in this position you will have:

• Minimum of 5 years' experience successfully performing the role of Statistical Programmer within the clinical research/pharmaceutical industry.
• Knowledge of other programming languages like R, Java is a plus.
• Passionate about programming. Always looking for better solutions, but has a critical view for not overengineering software.
• Advanced/expert-level SAS programming skills
• Is creative, brings ideas to the table and can perform well when given creative freedom.
• Display good communication skills, is able to explain ideas and can also listen well to ideas from others, can be self-critical.
• Thorough knowledge of and experience with CDISC standards is desired.
• Knowledge of ICH-GCP and other applicable legislation, with good understanding of clinical data and pharmaceutical development.
• Bachelors or higher degree in Science, Statistics, Information Technology or equivalent combination of education and related work experience.