Site Name: Belgium-Wavre, Italy - Rosia, Marburg - Office, Singapore - Tuas
Posted Date: Nov 12 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 Lead 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.

Key Responsibilities

In this role you will...

• Act as an essential partner within international cross-functional project teams by providing statistical expertise, e.g. for root cause investigations or improvement projects.
• Lead high-quality statistical analysis and reporting in accordance with regulatory and internal guidance (e.g. GSK QMS, GSK SOPs, Ph.Eur., ICH/FDA guideline). 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.
• Actively cooperate with global statistical community of GSK to develop, align and standardize data evaluation methods, methodologies and conventions. This especially includes cooperation with statisticians within MSAT, Quality, TRD and R&D organization
• Monitor and assess new developments, industry trends, evolving regulatory expectations. Constantly standardize and refine statistics in order to assure application of state-of-the-art statistical methodologies.
• Manage external and internal collaborations with statistical thought leaders and statistical groups in other functions and divisions. Represent GSK at internal and external boards. Influence external environment (e.g. regulators) by means of presenting at key conferences and publishing. Interaction and influencing of key regulators, FDA or other regulatory agencies in the context of submission of dossiers, variations etc
• Coach, mentor and train non-statisticians as required on the appropriate use of statistical methodologies and data evaluation tools for their business processes.
• Coach, mentor and oversee less experienced statisticians in the group and the organisation.

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
• Excellent 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
• Ability to manage networks and build relationships transversally across GSK.

Preferred Qualifications:
The following skills are not required, just preferred:

• Ph D 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

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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