Job Information
ICON Clinical Research Senior Clinical Data Science Lead in Remote, United States
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
What you will be doing:
Partake in development of advanced analytics for RBQM activities, including Quality Tolerance Limit (QTL) analysis and Key Risk Indicators (KRI) to support identification of important study issues which require monitoring, management, and adaptation of study plans
May map, manage, and design RBQM dataflows to integrate with other relevant clinical and operational databases at study, program, and enterprise level
Develop specifications and perform technical configuration of RBQM solution based on Study Risk Assessment (SRA)
Perform analyses in CSM Platform, interpret anomalies, and assist with explanation of complex findings
Summarize findings and communicate (written report or oral) results to stakeholders
Participate in developing and improving training materials for RBQM Enablement solutions
May provide internal and external training on RBQM solutions, as required
Develop and maintain library of QTLs and KRIs for studies across TAUs
Write signals based on critical data and critical processes as defined in the SRA
Assist RBQM Operations and study team with the investigation and explanation of complex CSM signals and outputs
Ensure that appropriate documentation is produced and maintained in the Trial Master File
May serve as technology Subject Matter Expert (SME) for RBQM platform and clinical data flow
Collaborate with Associate Director, Enablement to troubleshoot technical issues related to RBQM solutions
Participate in the development, evaluation, and continuous improvement of RBQM and Adaptive Monitoring solutions
Assist RBQM Enablement leadership in responding to technology questions, requests, and audits
May perform line management of other (junior) staff within RBQM Enablement
You are:
Bachelor’s Degree in a health-related, life science area or international equivalent preferred, or equivalent combination of education, training, and work experience
Minimum of 5 years of experience in the pharmaceutical or CRO industry
Minimum of 3 years of experience in clinical data management and/or SAS programming supporting statistical analyses
Advanced knowledge of broad drug development process and expertise in the cross-functional interfaces for the adoption of Risk Based Quality Management
Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, and WHODRUG
Solid understanding of the drug development process and clinical trial execution
Knowledge of RBQM IT systems
Experience with implementing RBQM Central Statistical Monitoring solutions
Strong technical understanding of statistical analyses, and the use of SAS programming language in the processing of clinical data, including data transformations, derivations, formatting, and reporting
Strong Technical understanding of how data flows across RBQM applications and the rest of Takeda’s R&D IT portfolio, including clinical and operational databases at study, program, and enterprise level
Demonstrated aptitude for data analytics and understanding of statistical concepts
Strong track record of building solid partnerships and cross-functional collaborations
Supports a culture of continual improvement and innovation; promotes knowledge sharing
Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo
Requires approximately 0-10% travel, including overnight and international travel to other Takeda sites, strategic partners, and therapeutic area required travel
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 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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 or submit a request here (https://careers.iconplc.com/reasonable-accommodations) .
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.
ICON Clinical Research
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