Manager - Clinical Analysis Standards

Site Name: Bengaluru Luxor North Tower Posted Date: Nov 25 2022 Is there any greater challenge than getting ahead of disease? 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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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 Analysis Standards Have you ever wanted to completely transform the standards to drive efficiency and quality by designing, creating, maintaining, and delivering analysis standards compliant with all applicable regulatory and industry requirements across all of GSK’s disease areas (i.e., including Vaccines, Oncology, Respiratory etc)? Within GSK’s Clinical Analysis Standards team is offering exactly that opportunity – to harmonize standards that enables automation of processes and systems, to simplify and monitor standards impact on pipeline delivery. If you want to be part of an agile team of exceptional standards experts, 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 standards to define near and long-term roadmap for delivery of standards for data transformation and statistical outputs supporting the clinical data analysis and reporting pathway. You will work with Statistical Programmers, Statisticians, Standards Experts (end to end) and Data Engineers, working in collaboration with cross-functional leadership, to design, develop and deploy robust standards 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 analysis & reporting standards (including 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 standards Provide direct support for standards, including tracking, prioritisation and resolution of user queries and issues Provide subject matter expertise to cross-functional teams including participation in innovation projects Plan and direct GSK representation on external standards teams including relevant CDISC Provide input into the design and testing of standard tools and applications when required Have a growth mindset, ready to shape the modernization of standards in pharma development, learning and applying your experience in collaboration with internal and external partners. What will your work look like? You’ll be an expert in standards for analysis and reporting (including CDISC ADaM etc), knowledgeable in all e2e clinical information standards and advise on their implementation at all levels of the organization You’ll drive and guide the use of standards in the delivery organization in collaboration with the Data Standards Organization and governance You’ll support delivery teams in the use of standards for statistical reporting You’ll perform or co-ordinate impact analysis on changes to standards and requests for new standards with the other standards leads, tool/asset managers and development teams You’ll monitor external regulations and standards to ensure GSK is compliant and up to date with the latest information You’ll play a key role in modernising the way that standards 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 Biostatistics experience Minimum of 5 years of experience of working with CDISC standards for Analysis & Reporting Experience of standards governance processes and implementing standards Knowledge of GxP, ICH requirements, and external regulations that govern drug development (where applicable) Working knowledge of therapeutic area or industry relevant projects such as oncology or clinical trials Ability to understand business problems and create innovative solutions Define and create business requirements and manage the backlog Track record of successful project delivery Excellent listening, communication, collaboration, and problem-solving skills Preferred Qualifications If you have the following characteristics, it would be a plus: Experience of leading standards governance processes Good knowledge of SAS/R/Python and/or other data science languages Experience in agile practices and tools, e.g., use of Git / JIRA / DevOps etc Excellent data modelling, data engineering and/or programming skills and experience Awareness/Knowledge of linked data, semantic ontologies 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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