Manufacturing Principal Statistician - Military Veterans

Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Nov 14 2024

Do you want to work for one of the world's leading pharmaceutical and healthcare companies, applying your statistical skills and innovative statistical methodology to make key contributions to the manufacture of critical medicines?

We have an exciting opportunity for a statistician to join our Digital and Data Science group, dedicated to supporting the launch of medicinal products to market and their subsequent product lifecycle within manufacturing. We are looking for an experienced non-clinical statistician to provide statistical support to manufacturing locations across the globe. In this role you will have the opportunity to collaborate with scientific colleagues in multidisciplinary teams in order to embed statistical thinking within projects whilst designing experiments and analysing data. This is an exciting opportunity to use your applied statistical skills to lead statistics capability build across a number manufacturing sites, providing ample opportunity to coach key individuals to acquire the skills needed for data driven decision making. Our team is part of global MSAT's Digital and Data Science organisation - a group of statisticians, data scientists, informatics and digital transformation experts with the mission to ensure data driven decision making is core to global MSAT's day to day activities.

We are looking for this role to be based at our key biologics site in Upper Merion, Pennsylvania.

In this role you will...

• Lead high-quality statistical analysis and reporting in accordance with regulatory and internal guidance. Typical applications include planning and evaluation of experiments, sample size calculation, process and method validation, assay or process transfers, assay or process trending and root cause analysis investigations.
• Use a wide range of statistical methodologies including statistical process control, equivalence testing, linear modelling, design of experiments, acceptance sampling, multivariate methods and modelling using frequentist and Bayesian approaches.
• Act as an essential partner within international cross-functional project teams by providing critical statistical support to route cause investigations. Provide statistical expertise to the team and help them interpret statistical outputs to use alongside other scientific understanding to champion data driven decisions aligned to GSK values.
• Work closely with colleagues in R&D on new products to ensure a smooth knowledge transfer whilst providing instrumental support to enable the launch of new products to market.
• Ensure integrity of statistical evaluation by ensuring application of appropriate statistical methodologies and traceability / reproducibility.
• Ensure compliance of data analyses with internal and external requirements (e.g. GSK QMS, GSK SOPs, Ph.Eur., ICH/FDA guideline).
• Monitor and assess new developments, industry trends, evolving regulatory expectations. Constantly standardise and refine statistics in order to ensure application of state-of-the-art statistical methodologies.
• Coach, mentor and train non-statisticians as required on the appropriate use of statistical methodologies and data evaluation tools for their business processes. Train and coach less experienced associates in the group and the organisation.
• Actively participate with the global statistical community of GSK to develop, align and standardise data evaluation methods, methodologies and conventions.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Masters degree in statistics, biostatistics or Bachelors degree in statistics, biostatistics with significant relevant experience
• Knowledge of statistical methodology in several of the following areas: Statistical process control, acceptance sampling, experimental design (DOE), linear regression, analysis of variance (ANOVA), measurement systems analysis (MSA), variance components analysis, equivalence analysis, tolerance intervals, mixed models, Monte Carlo simulation, Bayesian methodology, and analysis of high-dimensional data (MVA)
• Experience in the use of statistical software (e.g. Statistica, SAS or JMP) including at least one programming language (e.g. SAS or R)

Preferred Qualifications:

The following skills are not required, just preferred:

• PhD in statistics, biostatistics, or a closely related field with formal statistical training
• 2+ years' experience in statistical consulting, working alongside non-statistical colleagues to devise practical statistical solutions for inquiries, ideally within a pharmaceutical manufacturing setting
• Excellent oral and written English communication skills
• Knowledge of core API and drug product tests, unit operations and product control strategies across multiple dose forms
• Experience of communicating complex information in logical and simplified terms at different levels
• Ability to independently manage workload and communications with stakeholders

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

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.

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GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

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