Site Name: Bengaluru Luxor North Tower Posted Date: Nov 14 2024 Years of Experience: 8-12 years Skill Set / Exposure: End to End Clinical Data Analysis and Reporting, Project Management, SAS, R Programming, CDISC Standards. Work Location: Bengaluru [Hybrid Mode (3 days office)] Responsibilities: Acts as key statistical programming contact for study related stakeholders and provide solutions to complex problems. Performs the activities required of Study Lead Programmer (Global) role and may take SLP role for studies. Develops good understanding of Project Programmer role and may take on Shadow Project programmer role. Demonstrates strong programming expertise, with the ability to execute a wide range of programming activities with minimal supervision. Plans, manages and executes programming activities across multiple studies, asset(s), indications, or function to deliver all data analysis outputs to agreed timelines and quality, (e.g., macros, analysis datasets, pooled datasets, tables, figures and listings for regulatory submissions and publications). Oversees outsourced tasks to third party vendors and ensure their performance meets the agreed timelines and quality requirements established for the project or study. Defines, develops, and embeds data standards within a function, or therapeutic area in accordance with industry standards. Reviews and inputs into key documents at the project level (e.g. submission documents, clinical report, and publication). May author or co-author reporting analysis plans and department level documents (e.g. SOPs, working practice document). Participates in the review of other study delivery components (e.g. case report forms, study databases). Drives efforts to upscale quality and efficiency of programming activities within team/projects Proactively anticipates/identifies technical programming problems; defines criteria for assessing alternative solutions and determines the optimal approach; makes decisions in face of unusual and conflicting information. Anticipates compliance, quality or governance issues and proposes solutions to achieve resolution at asset or process level. Provides input or prepare detailed oral or written summaries in the context of strategic fit, feasibility, and rationale for projects and/or business initiatives as appropriate to audience. Provides mentoring, training, development, and performance feedback. Allocates decision-making authority and task responsibilities to appropriate direct reports / team members, utilizing time, skills and potential effectively. Manages stakeholders both internal and external and work effectively within cross-functional teams across the organization. Supports future direction/wider objectives of project or business. Basic Qualifications & Skills: Bachelor’s degree in engineering, Biotechnology, Computer Applications, or related disciplines. Strong expertise in CDISC standards and its application. Strong knowledge of Good Practice (GxP), and International Council for Harmonization (ICH) requirements. Proven track record of leading studies and projects in clinical trial setting. Advanced proficiency in one or more statistical programming languages, such as SAS, R or Python. Advanced macro development and debugging and developing complex programming skills. Effective written and verbal communication skills. Excellent influencing skills, which are applied effectively at all levels of an organization and across multiple functions. Strong time management skills; able to effectively organize and manage a variety of tasks across different projects. Preferred Qualifications: MSc or equivalent postgraduate qualification in Data Science, Mathematics, Statistics, Computer Science or related subject preferred. Solid understanding of the pharmaceutical regulatory and publishing processes (e.g., 21 CFR Part 11). Experience with using other clinical data analysis and reporting tools, such as R-Shiny, Spotfire, SAS Azure, or S-Plus. Advanced expertise in end-to-end clinical trial process and application of key clinical documents. Experience with mentoring and supervising junior programmers on technical tools and concepts. Experience with outsourcing of statistical programming work in the clinical trials setting (e.g., working with CROs, academic institutions, etc.) Expertise in representing programming function in cross-functional meetings, initiatives, and working group. Strong interest or experience in contributing to external organizations (e.g., PHUSE, PharmaSUG, IASCT, etc.). Therapeutic area expertise - Oncology preferred. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. 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