Lead Programmer

Site Name : Bengaluru Luxor North Tower Posted Date : Oct 22 2025 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 study-level risks associated with programming activities. Ensure tools, processes, and standards 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 provide technical support 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 Review and advise on programming specifications, analysis plan (SAP), protocol, case report form (eCRF), end-to-end data strategy, and data management documents. Develop in-depth knowledge of study design, protocol, submission standards and indication domain data & 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 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. Be familiar with 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. Gain expertise in leveraging AI technology and building 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. Adopt new technologies and methodologies to improve programming efficiency and data analysis capabilities. Familiarity with 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 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 programming related process deviations. Ensure all programming activities comply with 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. Uphold and contribute to 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 or co-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) Leadership and Team Development Present on technical and leadership topics at internal forums. Keep abreast of technological and other CP related advancement. Participate in cross-functional workshops and initiatives. Identify clinical programming related operational issues and support resolutions. Foster a positive team culture that embraces continuous improvement, collaboration, and innovation. Provide effective guidance, direction, and mentorship to junior programmers and SLPs to achieve high performance and support their professional growth. 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 a solid understanding of the end-to-end clinical trial process, statistical programming principles, and stakeholder engagement abilities. Demonstrated experience in CDSIC standards, programming using R, ADaM and SDTM development, study leadership and oversight, technical and non-technical communication, and study management are required. Preferred to have Respiratory experience. Other Job-Related Skills : Proficient in advanced programming languages (e.g., R, SAS, Python) and familiar with data analysis and project management tools. 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