Senior Statistician

Site Name: Belgium-Rixensart Posted Date: Aug 1 2022 Job purpose: When it comes to developing the Vaccines of the future, we’re looking for real experts who are interested in working in the stimulating environment of an international healthcare company. If you have strong ambition, solid technical skills and passion for innovation and global-working, and you want to make a difference to patients’ lives then YOU could be the future of GSK Vaccines business. As a Senior Statistician, you’ll join a global team of statistics experts (Global Projects Statistics team) to bring all aspects of non-clinical statistics in Technical Research & Development during product, process and analytical development, regulatory approval, technical transfer and commercialization of new Vaccines. You’ll be an essential and accountable partner of technical project teams, management and key stakeholders in the organization in providing statistical expertise. You’ll apply fit-for-purpose, advanced and state-of-the-art statistical principles in a wide variety of situations. You’ll Influence internally and externally to adopt rigorous and sound statistical approaches which have large organizational, strategic and business impact. Your responsibilities: · You act as essential partner for project technical teams (e.g. Technical Development Leader, functions representatives, ...) or other stakeholder groups and provide statistical expertise in all aspects of Technical Research & Development (Product, Process and Analytical Development and commercialisation) bringing the added value of data-driven decisions. · You ensure full integration of statistics across functions into everyday work as appropriate based on a close and deep partnership with scientists. You ensure advanced statistical concepts are routinely being applied during the development of product (e.g. stability modelling), process (e.g. modelling and simulation of biopharmaceutical process) and analytical methods (e.g. bioassays development) to ensure competitive and state of the art quality and productivity. · You take full ownership and accountability of all statistical content in a QbD framework. Typical applications include the establishment of experimental strategies and the evaluation of experimental results for process / analytical method development and validation, technical transfers, critical investigations etc. · You master a broad range of statistical sciences applications, such as linear model, DOE, sample size, multivariate analysis, modelling, simulation, machine learning, ... with knowledge of statistical and programming software (e.g. SAS, R, JMP, Python, ...). · You upskill the organisation on the application of statistics by providing training. · You ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance. · You manage external and internal collaborations with statistical thought leaders and statistical groups in other functions and divisions. You influence GSK internal policies, guidelines and Standard Operating Procedures (SOPs) to ensure appropriate statistical application and represent the organization on key conferences and advocacy groups in order to influence the external and regulatory environment. · You provide statistical expertise for all global development in compliance with current ICH / FDA, QbD guidelines and SOPs. · You stay up to date with latest developments in the field of statistics and explore CMC applications for our organization. · You support improvement of data collection and management to enable quick and reliable data analysis. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: · University degree (Master / PhD) in Data Science, Statistics, Mathematics, or related field · Ideally > 7 years relevant work experience in applying statistics within industry, preferably pharmaceutical environment · Fluent English required; second language desirable (e.g. Italian, French) Preferred qualifications: If you have the following characteristics it would be a plus: · Experience of working in global and agile cultural teams · Experience in cross-functional teams · Ideally experience in Quality by Design as applied to biologics and vaccines · Ideally knowledge of vaccines industry, especially in the development, approval and commercialization of vaccine products · Continuous learning and entrepreneurial mindset to support implementation of GSK’s digital strategy · Strong communication, collaboration and influencing skills Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements. Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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