Programming Manager

• 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
• 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
• 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
• 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
• 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
• 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
• 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

• A bachelor's degree in computer science, statistics, mathematics, life sciences, information technology, or a related field
• 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
• Deep understanding of the end-to-end clinical trial process, statistical programming principles, and stakeholder engagement abilities
• Highly proficient in advanced programming languages (e.g., R, SAS, Python) and familiar with data analysis and project management tools
• Solid understanding of workflow tools like Jira
• 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

Oncology experience