Senior CDSL 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 - As a Senior Clinical Data Science Lead at ICON, you will lead the analysis, interpretation, and management of clinical data to drive the success of our clinical trials. What You Will Do: You will oversee clinical data science workstreams, ensuring deliverables meet quality and timeline expectations. Key responsibilities include: * Responsible for leading data management activities for in-house and outsourced studies; * Responsible for vendor oversight activities across global development programs. Represents data management function on the Clinical Sub-team ensuring aligned expectations for all data related deliverables, especially in support of key decision points and regulatory submissions. * Contributes influential leadership in collaboration with other stakeholders to ensure established milestones and deliverables are met with the highest degree of quality. * Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. * Partners with appropriate stakeholders to resolves issues escalated from the vendor and/or cross-functional teams. * Leads and manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks. (d) May oversee above activities at the program level. * Participates in preparing function for submission readiness. * Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Ensures achievement of major data management deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Statistical Programming and Statistics. * Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables Your Profile: You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: *Bachelor's degree in life sciences, computer science, or a related discipline * Preferred 6+ years of experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function. * Proven track record of strong project management skills and experience managing data management activities for large drug development programs. * Experience with all phases of development in one or more therapeutic areas preferred. * Ability to handle multiple development programs simultaneously. * NDA/CTD Experience preferred. * Strong knowledge of data management best practices & technologies as applied to clinical trials. * Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. * Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. * Advanced knowledge of broad drug development process with expertise in the cross-functional interfaces with the data management function. * Advanced knowledge of office software (Microsoft Office). * Experience with budget planning & management. * Strong knowledge of relational databases and experience using multiple clinical data management systems. * Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models. * Ensures adherence to functional budget, and provides timely updates to manager regarding additional, potential spend or cost savings. * Expert knowledge of CDISC standards, SDTM preferred. Good experience leading standards selection and implementing in clinical trials is ideal. * Expert knowledge of general of medical terminology, medical coding, laboratory reference ranges, clinical diagnostic procedures, anatomy/physiology and nature of disease processes. #LI-JC3 #LI-Remote 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 maximize 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 site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here. 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. Are you a current ICON Employee? Please click here to apply

Overview IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. IQVIA has two teams focused exclusively on amplifying the patient’s voice and enhancing their experiences across their health journey: the Patient-Centered Solutions and Connected Technologies (PACT) team, and the Instrument Licensing Solutions and Patient and Site Strategy (ILS & PASS) team. These teams work closely together to generate patient experience data (PED) through clinical outcome assessments (COAs; including digital health technologies), qualitative research, and patient preference research. The ILS & PASS team has a small group dedicated to thought leadership and COA instrument development. This “science team” is focused on (a) ensuring that sound scientific principles permeate through the research completed by the PACT and ILS & PASS teams, and (b) leading the development, validation, and qualification of COA instruments to collect reliable and interpretable data from patients in medicines development and routine clinical care. The ILS & PASS science team comprises dedicated qualitative scientists and COA development scientists. Presently it does not have a team of dedicated statisticians and psychometricians. Owing to the large body of work – mostly internally funded – the team is recruiting for a Statistics and Psychometrics Lead, one entry-level Statisticians/Psychometrician, and one Statistical Programmer to support the teams’ activities, as described below. The Statistician/Psychometrician and Statistical Programmer roles will report to the Statistics and Psychometrics Lead. The Statistician/Psychometrician role is described below. Role & Responsibilities The Statistician/Psychometrician will be expected to: (1) Empirically develop scoring rules & program scoring algorithms for existing COA measures - For instruments being added to IQVIA ILS library, generate standard scoring documentation, and program simulation datasets, Data Quality Evaluation (DQE), and scoring of domains on these datasets - Implement new statistical features in the random generation of data, to simulate real-world instrument data with certain psychometric properties - Implement new, more advanced statistical capabilities in user tools (Insights Hub, PROCore) - Work cross-functionally with non-statisticians/psychometricians in the PACT and ILS & PASS teams (2) Provide statistical support for the development of new COA measures & endpoints - Program and conduct classical and modern psychometric analyses - Program and conduct analyses of meaningful thresholds - Develop, validate, and score DHT-derived measures, and composite scores from multimodal data sources (COA + sensor-derived data). - Process and model high frequency and continuous DHT data, including time series modelling. - Collaborate with data scientists to support algorithm validation, and verification of digital measure performance across diverse datasets and devices. (3) Provide statistical support for the COA Accelerator (COAA) tool - Support the COA Accelerator team as a subject matter expert for statistics, psychometrics and scoring of COAs - Review COA Accelerator content in support of client subscriptions (4) Support thought leadership activities - Participate in scientific thought exchanges both to develop self and to share relevant experiences with others - Publish research papers in medical/scientific journals and represent IQVIA at internal and external conferences About You Knowledge, skills and abilities - Candidates must have: (a) statistical and psychometric research skills; and (b) strong computer skills (including SAS and R). - Candidates should demonstrate: (a) excellent written and oral communication skills including grammatical/technical writing skills; (b) critical attention and accuracy with details; and (c) strong individual initiative, organizing skills, and commitment to quality. - Candidates must be able to: (a) work within a team environment, and to establish and maintain effective working relationships; (b) confidently communicate with, and effectively present information to, internal and external teams; and (c) work in a fast-paced environment with demonstrated ability to effectively manage multiple tasks and projects. - Candidates should have extensive familiarity and demonstrable experience with AI tools and their application to the topics mentioned above. Education and experience - Candidates should have an advanced degree in statistics or psychometrics and an interest in patient-centered research (including COA and/or DHT) and clinical research (pharmaceutical, or healthcare industry). - Consulting experience with pharmaceutical companies is desirable. Physical requirements - Candidates can expect to use telephone [and face-to-face] communication extensively, requiring accurate perception of speech. Extensive use of a keyboard is also expected, requiring repetitive motion of fingers. Candidates will also need to sit for extended periods of time (daily), and travel as required (<10%). This role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Clinical Data Science Lead 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 As a Clinical Data Science Lead at ICON, you will drive data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions. What You Will Do: You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes. * Participates in study level vendor oversight activities. May represents data management function on the Clinical Sub-team ensuring aligned expectations. especially in support of key decision points and regulatory submissions. * Serves as a first point of contact for CROs partners when collaboration is needed to ensure established milestones and deliverables are met with the highest degree of quality. * Partners with appropriate stakeholders and CRO partners to mitigate and resolve risks. * Leads and manages clinical trial data collection set-up, data review, and database lock: (a) Works with other functions to complete set up of EDC and other study data collection tools such as IRT, ePRO and eCOA. (b) Leads the creation and maintenance of study data cleaning plan components, including edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plan(s), coding guidelines, SAE reconciliation guidelines, database lock plans. (c) Leads data review, including query management, and leads activities required for interim and final database locks. * Participates in preparing function for submission readiness and may represent function in a formal inspection or audit. * Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents. * Tracks study deliverables and evaluates study metrics to mitigate risk for major data management deliverables and milestones. * Responsible for the planning and management of external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting. * May prepare metrics to support the function’s KPIs. * Contributes to functional Continuous Improvement initiatives, providing expertise and ensuring deliverables are provided on time, to budget, and in alignment with company, departmental or functional requirements. * Works cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables * Champions and adopts technology improvements and tools for use in clinical data management processes. Your Profile: You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team. Required qualifications and experience: *Bachelor's degree in life sciences, computer science, or a related discipline * Preferred 4 + years experience in data management and/or drug development process with expertise in the cross-functional interfaces with the data management function. * Proven track record of strong project management skills and experience managing data management activities for large drug development programs. * NDA/CTD Experience preferred. * Strong knowledge of data management best practices & technologies as applied to clinical trials. * Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes. * Strong knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. * Good understanding of CDISC standards. Some experience in standards development, implementation and maintenance is ideal. * Advanced knowledge of office software (Microsoft Office). * Strong knowledge of relational databases and experience using multiple clinical data management systems. * Good working knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models. #LI-JC3 #LI-Remote 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 maximize 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 site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here. 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. Are you a current ICON Employee? Please click here to apply

• Lead the strategic vision and execution of AIR’s most complex and high-impact data science projects. • Design and implement cutting-edge analytical frameworks, including AI/ML models, to extract insights from diverse and high-dimensional datasets. • Serve as a senior technical advisor across AIR’s research domains, including education, health, workforce, and international development. • Spearhead the integration of novel data sources (e.g., geospatial, unstructured, real-time) into AIR’s research and evaluation efforts. • Guide the development of scalable data pipelines and reproducible research environments. • Represent AIR in external forums, including conferences, advisory boards, and collaborative partnerships. • Author influential publications and thought leadership pieces that advance the field of data science for social good. • Mentor senior data scientists and technical staff, fostering innovation, technical excellence, and career growth. • Lead cross-functional teams and collaborate with economists, policy researchers, and technologists to deliver integrated solutions.