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
Agile Methodology, Clinical Development, Data Engineering, Data Science, Learning Agility, Problem Solving, Statistical Programming
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
Inclusion at GSK:
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at [email protected] to discuss your needs.
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