Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead clinical programming for multiple studies, ensuring high-quality, regulatory-ready data and reports. You will work closely with statisticians, data managers, clinical colleagues, and external partners. We value clear communication, practical problem solving, and a coaching mindset. This role offers significant growth, the chance to mentor others, and a meaningful impact aligned with GSK’s mission to unite science, technology, and talent to get ahead of disease together. Join us to build your career where your work truly matters. Key Responsibilities: 1) Accountability • Develop and manage the study roadmap in alignment with the Clinical Study Action Plan (CSAP) and Project Roadmap. • In collaboration with PP, generate study priorities, timelines, backlogs, and sprints within the Agile framework. • Proactively identify, monitor, and escalate risks associated with programming activities for their studies and develop understanding of the impact at the project level. • Develop advanced expertise in using the tools, processes, and standards and ensure these are implemented within the study. • Ensure Key Performance Indicators (KPIs) related to statistical programming and data strategy are met, including contribution to the Trial Master File (TMF). • Lead and contribute to the execution of programming deliverables such as: SDTM and ADaM datasets; tables, listings, and figures (TFLs) related to the Clinical Study Report; annotated case report form (aCRF); output specifications (i.e. mock shells); regulatory documentation such as reviewers’ guides, define.xml, and Health Authority responses. • Maintain accurate and timely data in resource forecasting tools, project milestone planning tools and collaboration workflow tools. • Create oversight plan and implement Sponsor oversight for outsourced studies. 2) Technical & Scientific Expertise • Author or advise on programming specifications, analysis plan (SAP), protocol, case report form (eCRF), end-to-end data strategy, and data management documents. • Maintain and demonstrate in-depth knowledge of study design, protocol, submission standards and indication domain data and endpoints. • Utilize high-level expertise in programming languages (e.g., R, SAS) to develop and support clinical trial data analysis. • Provide expert advice and guidance on complex technical issues, ensuring best practices are used across the programming team. • Lead discussions on programming and data strategies, displays, and custom programs, adapt to new tools/process/multilingual programming. • Keep abreast of GSK standards, processes, and updates; mentor and inform the programming team accordingly, guide stakeholders to better understand Programming deliverables and timeline planning, storytelling of milestones/deliverables. • Solid understanding of workflow tools like Jira. 3) Innovation, Problem Solving & Decision Making • Proactively identify risks and propose solutions, active involvement to after action review discussions (AAR). • Make data-driven decisions that optimize programming processes and enhance study operations. • Demonstrate ability to leverage AI technology and develop R-based tools to promote automation, enhance programming efficiency, reduce reporting duration, and increase quality. • Consult with PP and subject matter experts on programming requirements and propose effective, innovative solutions for complex tasks. • Solid understanding of AGILE principles (e.g., flexibility, collaboration, and continuous improvement) and how to effectively apply them within the context of STOM and study activities. 4) Compliance, Quality and Governance • Advocate for & adhere to rigorous quality control to ensure and maintain the accuracy and reliability of data and analysis outputs and submission and audit readiness. • Ensure programming’s adherence to process, take corrective action for any deviations. • Ensure all programming activities comply with GSK SOPs, industry standards and regulatory requirements, such as FDA and EMA guidelines. • Oversee compliance with Trial Master File (TMF) requirements to maintain regulatory standards. • Ensure timely archival of completed programming deliverables and documentation. • Establish and uphold governance frameworks to ensure consistent application of programming standards and practices. • Identify risks early and devise mitigation plans, timely escalation for quicker action and follow-up. 5) Communication and Influence • Implement DIA and SPADM principles for effective meetings and faster decision making. • Articulate complex technical information effectively to both technical and non-technical audiences, ensuring transparency and understanding of programming activities and timelines. • Collaborate with statisticians and (PP) to plan and proactively identify datasets and outputs for re-QC (including Risk Based QC) for outsourced studies. • Collaborate effectively to define and document study processes, ensuring comprehensive understanding and alignment among programming and matrix team members. • Maintain proactive communication with stakeholders to manage expectations and address risks effectively. • Play a pivotal role in influencing project direction and decision-making by presenting compelling data and insights. 6) Collaboration and Matrix-Working • Develop and sustain strong working relationships with stakeholders to foster a collaborative environment. • Initiate and maintain project management tools and “Responsible Accountable Consulted Informed” matrix (RACI). • Engage stakeholders and review progress regularly (example: active participation in STOM providing necessary inputs in working group meetings). • Lead programming meetings and kick-off meetings (KOM). • Closely collaborate with PP and Agile leaders to ensure sufficient resources and monitor any change in study plan which impacts the resource planning. • Take accountability in developing the timelines, ensure these timelines are updated in tracking tools consistently. • Effectively discuss the study requirements and timelines with PP and cross-functional teams for alignment and ensure clarity on tasks and timelines among team members. • Facilitate seamless integration across matrix teams, leveraging collective expertise for optimal project outcomes. 7) Study Leadership and Team Development Support • Present on technical and leadership topics at internal and external forums. • Keep abreast of technological and other CP related advancement and innovation in the industry and collaborate with internal teams to explore utility and adoption. • Participate and represent clinical programming in cross-functional workshops and initiatives. • Own clinical programming related operational issues and drive resolutions. • Foster a positive team culture that embraces continuous improvement, collaboration, and innovation. • Provide effective guidance, direction, and mentorship to other programmers and SLPs to achieve high performance. • Support the professional growth and career development of team members by helping them identify skills and capabilities. • Regularly seek feedback on own and provide feedback on others’ performance, identifying areas where development may be beneficial. Education Requirements A bachelor's degree in computer science, statistics, mathematics, life sciences, information technology, or a related field. Job Related Experience • Using examples from past and current work experience, a successful candidate will be able to demonstrate deep understanding of the end-to-end clinical trial process, statistical programming principles, and stakeholder engagement abilities. • Demonstrated advanced expertise in CDSIC standards, programming using R, ADaM and SDTM development, study leadership and oversight, technical and non-technical communication, and study management are required. • Prefer to have Oncology experience. Other Job-Related Skills Highly proficient in advanced programming languages (e.g., R, SAS, Python) and familiar with data analysis and project management tools. Skills Agilité d’apprentissage, Développement clinique, Influencer sans autorité, Ingénierie des données, Leadership Agile, Méthodologie Agile, Programmation statistique, Résolution de problème, Science des données Pourquoi GSK? Allier science, technologie et talent pour vaincre ensemble la maladie. GSK est une entreprise biopharmaceutique mondiale dont la mission est de réunir la science, la technologie et le talent pour prendre ensemble de l'avance sur les maladies. Nous visons à avoir un impact positif sur la santé de 2,5 milliards de personnes d'ici la fin de la décennie, en tant qu'entreprise prospère et en croissance où les gens peuvent s'épanouir. Nous prenons de l'avance sur les maladies en les prévenant et en les traitant grâce à l'innovation dans les médicaments spécialisés et les vaccins. Nous nous concentrons sur quatre domaines thérapeutiques : les maladies respiratoires, l'immunologie et l'inflammation; l'oncologie; le VIH; les maladies infectieuses – pour avoir un impact à grande échelle sur la santé. Les gens et les patients partout dans le monde comptent sur les médicaments et les vaccins que nous produisons; c'est pourquoi nous nous engageons à créer un environnement où nos employés peuvent s'épanouir et se concentrer sur ce qui compte le plus. Notre culture, qui repose sur l'ambition pour les patients, la responsabilité de la portée et le fait de faire ce qui est juste, constitue la base de la manière dont nous tenons nos engagements ensemble pour les patients, les actionnaires et nos employés. Inclusion chez GSK: En tant qu'employeur engagé envers l'inclusion, nous vous encourageons à nous contacter si vous avez besoin de tout ajustement pendant le processus de recrutement. 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