Key Responsibilities:
1) Accountability
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Develop and manage the study roadmap in alignment with the Clinical Study Action Plan (CSAP) and Project Roadmap.
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In collaboration with PP, generate study priorities, timelines, backlogs, and sprints within the Agile framework.
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Proactively identify, monitor, and escalate risks associated with programming activities for their studies and develop understanding of the impact at the project level.
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Develop advanced expertise in using the tools, processes, and standards and ensure these are implemented within the study.
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Ensure Key Performance Indicators (KPIs) related to statistical programming and data strategy are met, including contribution to the Trial Master File (TMF).
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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.
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Maintain accurate and timely data in resource forecasting tools, project milestone planning tools and collaboration workflow tools.
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Create oversight plan and implement Sponsor oversight for outsourced studies.
2) Technical Scientific Expertise
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Author or advise on programming specifications, analysis plan (SAP), protocol, case report form (eCRF), end-to-end data strategy, and data management documents.
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Maintain and demonstrate in-depth knowledge of study design, protocol, submission standards and indication domain data and endpoints.
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Utilize high-level expertise in programming languages (e.g., R, SAS) to develop and support clinical trial data analysis.
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Provide expert advice and guidance on complex technical issues, ensuring best practices are used across the programming team.
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Lead discussions on programming and data strategies, displays, and custom programs, adapt to new tools/process/multilingual programming.
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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.
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Solid understanding of workflow tools like Jira.
3) Innovation, Problem Solving Decision Making
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Proactively identify risks and propose solutions, active involvement to after action review discussions (AAR).
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Make data-driven decisions that optimize programming processes and enhance study operations.
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Demonstrate ability to leverage AI technology and develop R-based tools to promote automation, enhance programming efficiency, reduce reporting duration, and increase quality.
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Consult with PP and subject matter experts on programming requirements and propose effective, innovative solutions for complex tasks.
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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
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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.
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Ensure programming s adherence to process, take corrective action for any deviations.
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Ensure all programming activities comply with GSK SOPs, industry standards and regulatory requirements, such as FDA and EMA guidelines.
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Oversee compliance with Trial Master File (TMF) requirements to maintain regulatory standards.
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Ensure timely archival of completed programming deliverables and documentation.
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Establish and uphold governance frameworks to ensure consistent application of programming standards and practices.
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Identify risks early and devise mitigation plans, timely escalation for quicker action and follow-up.
5) Communication and Influence
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Implement DIA and SPADM principles for effective meetings and faster decision making.
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Articulate complex technical information effectively to both technical and non-technical audiences, ensuring transparency and understanding of programming activities and timelines.
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Collaborate with statisticians and (PP) to plan and proactively identify datasets and outputs for re-QC (including Risk Based QC) for outsourced studies.
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Collaborate effectively to define and document study processes, ensuring comprehensive understanding and alignment among programming and matrix team members.
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Maintain proactive communication with stakeholders to manage expectations and address risks effectively.
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Play a pivotal role in influencing project direction and decision-making by presenting compelling data and insights.
6) Collaboration and Matrix-Working
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Develop and sustain strong working relationships with stakeholders to foster a collaborative environment.
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Initiate and maintain project management tools and Responsible Accountable Consulted Informed matrix (RACI).
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Engage stakeholders and review progress regularly (example: active participation in STOM providing necessary inputs in working group meetings).
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Lead programming meetings and kick-off meetings (KOM).
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Closely collaborate with PP and Agile leaders to ensure sufficient resources and monitor any change in study plan which impacts the resource planning.
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Take accountability in developing the timelines, ensure these timelines are updated in tracking tools consistently.
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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.
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Facilitate seamless integration across matrix teams, leveraging collective expertise for optimal project outcomes.
7) Study Leadership and Team Development Support
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Present on technical and leadership topics at internal and external forums.
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Keep abreast of technological and other CP related advancement and innovation in the industry and collaborate with internal teams to explore utility and adoption.
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Participate and represent clinical programming in cross-functional workshops and initiatives.
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Own clinical programming related operational issues and drive resolutions.
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Foster a positive team culture that embraces continuous improvement, collaboration, and innovation.
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Provide effective guidance, direction, and mentorship to other programmers and SLPs to achieve high performance.
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Support the professional growth and career development of team members by helping them identify skills and capabilities.
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Regularly seek feedback on own and provide feedback on others performance, identifying areas where development may be beneficial.
Education Requirements
A bachelors degree in computer science, statistics, mathematics, life sciences, information technology, or a related field.
Job Related Experience
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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.
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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.
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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.
