Programming Manager - Clinical Reporting Solutions

Site Name: Bengaluru Luxor North Tower Posted Date: Jan 4 2023 Is there any greater challenge than getting ahead of disease? We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. Technical Excellence and Innovation We are investing in changing our technology strategy and delivery as part of Technical Excellence and Innovation (TechEx) team, which is designed to accelerate Biostatistics at GSK to industry Pre-eminence – that means Biostatistics should be THE BEST in the industry. TechEx mission is to enable people to deliver the required clinical data analyses with technology we enjoy using them. We do this by finding a better way of doing things, Centralizing and consolidating the development of cutting-edge tools Using the latest technology in data and analytics Transforming how we derive knowledge from information collected within clinical trials TechEx Pillars are, Innovation Enablement - To support innovation activities with skills and subject matter expertise in pursuit of solutions of our staff’s most impactful pain points Emerging Methodologies & Tools - To demonstrate the feasibility, viability, and desirability of cutting-edge methodologies to resolve business pain points through experimentation Product Incubation - To transform and scale solutions, preparing technically performant products with a user-centric design for wider use by our staff TechEx Tools - To enable our people, and hence the business, to deliver consistent quality quickly with a centrally provided set of trusted tools Enterprise Tools - To ensure the availability and suitability of business critical, and often LTO, enterprise-level assets for use by our people Data Enablement - To enable our people, and hence the business, to work with current and new forms of data with ease and confidence, delivering quality quickly Our workforce work as a matrix across all of the pillars in an agile way and currently we are geographically spread across Europe, India, United Kingdom and United States. Clinical Reporting Solutions Have you ever wanted to completely revisit the design of solutions that your teams use for clinical data analysis and reporting? Within GSK’s new SCE (SPACE) platform, we are offering exactly that opportunity – to design, develop, test, and deploy a 21st century set of user-centric, solutions for use by our pipeline delivery teams, based in both SAS and R, to truly enable programmers, statisticians, and data scientists to deliver clinical trial insights quicker, with less effort, and higher first-time quality. If you want to be part of an agile team of exceptional developers, using modern software development methodologies, as well as contribute to the wider strategic direction of Biostatistics’ Technical Excellence & Innovation (TechEx), then this role might be for you. Job Description As a member of the TechEx, you will apply your broad knowledge of clinical analysis & reporting solutions (and associated technologies) to define the near and long-term roadmap for delivery of user-centric solutions for data transformation and reporting output creation within GSK’s new SCE (SPACE) and associated platforms supporting the clinical data analysis and reporting pathway. You will work with a team of developers, data scientists, standards experts and data engineers, working in collaboration with cross-functional leadership, to design, develop, test, and deploy robust solutions to pipeline delivery teams increasing value, improving flow, and enhancing first-time quality. You will plan, lead & contribute to: Work with clinical programmers/statistical analysts and other internal customers to understand business requirements and industry regulations Design, create, maintain, and deliver standard analysis & reporting programming tools (including creation of ADaM, analysis data, displays and beyond) across all of GSK’s disease areas (Respiratory, Oncology, Vaccines etc.) Develop, maintain and deliver documentation and training material for analysis & reporting programming tools library Provide direct support for analysis & reporting tools, including tracking, prioritisation and resolution of user queries and issues Provide subject matter expertise to cross-functional teams including participation in innovation projects Have a growth mindset, ready to shape the modernization of our analysis & reporting tools, learning and applying your experience in collaboration with internal and external partners. What will your work look like? You’ll be an expert in SAS and associated software, including SAS ODS, in the context of the analysis and reporting of clinical data You’ll be knowledgeable in standards for analysis and reporting (including CDISC ADaM etc), and other clinical information standards and advise on code-based implementation of these at all levels of the organization You’ll drive and guide the use of standard analysis & reporting tools in the delivery organization in collaboration with the Data Standards Organization and governance You’ll support delivery teams in the use of standard analysis & reporting tools for statistical reporting You’ll perform or co-ordinate impact analysis on changes to standard analysis & reporting tools and requests for new tools with other tool/asset managers, standards leads and development teams You’ll play a key role in modernising the way that standard analysis & reporting tools support automation for data analysis and decision making We work in an agile way (Scrum / Scrumban) Basic Qualifications We are looking for professionals with these required skills to achieve our goals: Graduation, minimum 8 years of Biostatistics experience Expert in SAS programming, and script/macro code development, testing and validation Experience in writing and applying requirements and program specifications Experience with products such as JMP, SAS/GRAPH, SAS Output Delivery System Demonstrated knowledge of and experience in the application of CDISC data and standards Working knowledge of therapeutic area or industry relevant projects such as oncology or clinical trials Knowledge of GxP, ICH requirements and external regulations that govern drug development (where applicable) Effective in both oral and written communications, able to express ideas and incorporate feedback to produce a completed quality deliverable Preferred Qualifications If you have the following characteristics, it would be a plus: Experience in agile practices and software development lifecycle management and tools, e.g., use of Git / JIRA / DevOps etc SAS Certified Professional: Advanced Programming Using SAS 9.4 SAS Certified Clinical Trials Programmer Using SAS®9 At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. *LI-GSK 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. 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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. 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