Site Name: Belgium-Wavre
Posted Date: Dec 10 2024
Job Purpose
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 vaccines and medicines?
We have an exciting opportunity for a statistician to join our global Digital and Data Science group, dedicated to supporting the launch of medicinal products to market and their subsequent product lifecycle within manufacturing. Our team is part of global Manufacturing Science Analytical and Technology (MSAT) group. 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 of manufacturing sites, providing ample opportunity to coach key individuals to acquire the skills needed for data driven decision making.
We are looking for this role to be based at one of our key Vaccines site in Wavre (Belgium).
Responsibilities
- 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:
- MSc in statistics, biostatistics or closely related field with formal statistical training; or BSc in statistics, biostatistics, or a closely related field with formal statistical training and significant relevant experience
- Strong and diverse technical knowledge in statistics. 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 use of statistical software (e.g. JMP, SAS, R)
- Experience in writing code in R or SAS
- Good oral and written English communication skills with experience of communicating complex information in logical and simplified terms at different levels
- Background in statistical consulting, working alongside non-statistical colleagues to devise practical statistical solutions for inquiries
- Ability to independently manage workload and communications with stakeholders
Preferred Qualifications
The following skills are not required, just preferred:
- PhD in statistics, biostatistics, or a closely related field with formal statistical training
- Knowledge of core API and drug product tests, unit operations and product control strategies across multiple dose forms
- Background in statistical consulting within a pharmaceutical manufacturing setting
#Li-GSK
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.
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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