Principal Statistician (Manufacturing)

Job title:

Principal Statistician (Manufacturing)

Company

GlaxoSmithKline

Job description

The Statistics and Data Team within the MSAT (Manufacturing Science and Technology) function provides GSK’s Global Supply Chain (GSC) business with statistical/analytics tools with the aim of supporting GSK’s manufacturing and commercial aims. The team identifies trends and develops High-quality and fit for purpose statistical support.Job Purpose:The Principal Statistician role delivers statistical solutions to support new pharmaceutical product introductions interacting with R&D and supporting the scale-up to manufacturing scale. This include supporting regulatory submissions and validation activities (for new products) and root cause investigations and batch quality assessments (for established products), all aligned to the requirements of Product Lifecycle Management.You will also act as an essential partner for a variety of cross-functional global teams (including investigations, project teams and improvement projects) to provide statistical input to assessments and guide appropriate interpretation.As a Subject Matter Expert in Statistics you will work with a wide range of management (including senior stake-holders) to drive statistical capability across all sites and functions with GSK’s supply chain. This includes managing and influencing internal global networks to adopt rigorous and sound statistical approaches and standardise methodologies globally.You will have the opportunity to work on a wide variety of galenic forms, including Metered Dose Powder Inhalers, Metered Dose Inhalers, Oral Solid Dose, Vaccine, Biopharm and Drug Substances supporting manufacturing sites from USA, Europe, Emerging Markets and South East Asia.Key Responsibilities (includes):

• Act as an essential partner within cross-functional global teams by providing statistical expertise to help interpret statistical outputs and use these alongside other scientific understanding to drive outcomes aligned to GSK values. This especially includes contribution to the resolution of deviations and improvement projects.
• Provide statistical analysis, reporting and communication of results and conclusions in the form of technical documents and presentations in accordance with regulatory and internal guidance. Take full ownership and accountability of all statistical content. Typical applications include study design and sample size calculation, process and method validation, assay or process trending, assay or process transfers.
• Ensure high-quality statistical evaluation and reporting, e.g., for regulatory dossiers that set a benchmark in the industry and result in high regulatory acceptance. Ensure compliance of data with internal and external requirements (e.g. GSK QMS, GSK SOPS, Ph.Eur., ICH/FDA guideline).
• Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
• Review the statistical element of technical documents as a Subject Matter Expert.

About You:Strong experience in data-analysis is a pre-requisite for the role. You must also be accomplished in communicating / explaining complex statistical concepts (tools/models) to a wide range of clients and operating partners (who will not be statisticians). The role has considerable focus on providing problem-solving solutions.Please note: We are particularly interested in applicants with “R” coding knowledge/experience.CLOSING DATE for applications: Friday 2nd of May 2025 (COB).Basic Qualifications:

• Relevant statistical / mathematics / quantitative qualifications (eg; Masters degree or PhD with adequate statistical content, Bachelor Degrees can be considered depending on experience).
• Strong practical experience and understanding of statistical theory (required for the application and management of appropriate methodologies).
• Knowledge / experience of using “R”.
• Experience applying appropriate statistical methods (eg; hypothesis testing, mixed effects modelling, acceptance sampling, statistical process control, multivariate methods and Bayesian simulation techniques)

Benefits:GSK offers a range of benefits to its employees, which include, but are not limited to:

• Competitive base Salary
• Annual bonus based on company performance
• Opportunities to partake in on the job training courses
• Opportunities to attend and partake in industry conferences
• Opportunities for support for professional development and chartership
• Access to healthcare and wellbeing programmes
• Employee recognition programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage .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.GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.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 us on or 0808 234 4391. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the and scroll to the Careers Section where you will find answers to multiple questions we receive .Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at

Expected salary

Location

Hertfordshire

Job date

Sat, 19 Apr 2025 04:40:12 GMT

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