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Reference #: 399032 Site Name: GSK HQ, Belgium-Wavre, Italy - Parma, Italy - Rosia, Upper Merion Posted Date: Jul 4 2024

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.

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

As a Quality Statistician, you will provide quality oversight over all aspects of Data and Data Sciences including Statistics. The person will be in charge of the quality compliance of data management generated during statistical analysis of QC data.

In this role you will... Deliver Quality Oversight over data and data sciences related global risks, changes, deviations, CAPAs Quality oversight over data and data science related GSK internal policies,global SOPs and guidelines, such as specification guideline, guideline for stability data analysis, GFSOP for integrity of statistical evaluation. Ensure compliance with regulatory expectations (e.g. ICH/FDA guideline, Ph.Eur., ChPh) Consult and assist local sites and global functions for all compliance and Quality related aspects of data and data sciences. Drive data integrity and harmonization of statistical procedures over sites (local QC and MSAT) and global functions (e.g. MSAT process sciences, TRD, R&D). Quality oversight over statistical GxP reports requested by global functions, e.g. MSAT process sciences. Assure compliance with internal and external requirements (e.g. GSK QMS, Ph.Eur., ICH/FDA guideline). Assure compliance of validation strategy for complex statistical and data sciences models, such as digital twin, Real-Time Release, chemometrical models. Drive external and internal collaborations and networks with statistical thought leaders and statistical  groups in other functions and divisions. Represent GSK in internal and external boards. Influence external environment (e.g.regulators) by means of presenting at key conferences and publishing. Anticipate regulatory expectations regarding statistical and data sciences aspects, e.g. in the context of analytical or product robustness, stability, specification setting. Proactively seek for solutions, influencing regulators, and raising the bar for competitors. Oversight over communication to authorities related to data or data sciences topics, e.g. for submissions to assure compliance with regulatory expectations Influence external environment (e.g.regulators) by means of presenting at key conferences and publishing. Personal interaction and influencing of key regulators, FDA or other regulatory agencies, in the context of submission of dossiers, variations, etc. Permanent member of specification committee to assure QA compliance for all statistical aspects of specification setting.

Why you? Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: University degree in statistics, mathematics, data science, computer science or related field or comparable experiences. Significant experience within the pharmaceutical industry, preferably in various functions (i.e. R&D, manufacturing, Quality) Experience in personal inter ction with Health Authorities such as EMA, FDA etc. and in GMP / Quality by Design / Operational Excellence / Six Sigma beneficial Strong ability to translate quality related questions to statistical models with broad knowledge of pharmaceutical industries including vaccines. Agile and proactive working style and the ability to manage networks and build relationships transversally across the GSK network and beyond. Ability of working in a multidisciplinary multicultural setting and across geographic boundaries.

Preferred Qualifications & Skills: The below are preferred not essential: Degree Advanced University degree, e.g. Masters Degree, PhD

Closing Date for Applications: 25th July 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert.

When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.

We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people. 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. 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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact