MSAT Manufacturing Statistician

• Work in a global team of statistical experts to provide statistical support to Global Supply Chain sites and functions.

• Focus on the delivery of statistical analysis required to support new product introduction (e.g. regulatory submissions, validation activities) and established products (e.g. root cause analysis investigations, batch quality assessments) aligned to the requirements of Product Lifecycle Management.

• Act as an essential and accountable partner of cross-functional global teams (including investigations, task forces, improvement projects), management and key stakeholders in the organisation to provide statistical input to assessments and guide appropriate interpretation.

• As a Subject Matter Expert in Statistics, help build the statistical capability of GSC across all sites and functions

• Support 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.

• Carry out statistical analysis, report and communicate results and conclusions in the form of technical documents and presentations in accordance with regulatory and internal guidance. Take ownership and accountability of statistical content. Typical applications include study design and sample size calculation, process and method validation, assay or process trending, assay or process transfers.

• Ensure compliance of data analyses 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.

• Contribute to local and global documents with statistical content, e.g. SOPs, guidelines.

• Contribute to development and standardisation of data evaluation methodologies and conventions. This especially includes active participation with the wider statistics network (MSAT, Quality, TRD and R&D, as well as with the GPS community) to help ensure that best practises are incorporated into local ways of working.

• Assist with upskilling ofl the organisation through coaching, mentoring and training of nonstatisticians and junior statisticians as required on the appropriate application of statistics and data evaluation tools for their business processes.

• Master's degree in Statistics, Data Science, Mathematics, or a related field.

• At least 2 years of relevant experience in applying statistics, preferably in a pharmaceutical or manufacturing environment.

• Proficiency in statistical software (e.g., SAS, R, JMP, Python).

• Strong communication skills and ability to work collaboratively in cross-functional teams.

Preferred Qualifications:

• PhD in Statistics or related field.

• Experience with Quality by Design (QbD) principles.

• Familiarity with biopharmaceutical processes or vaccines industry.

• Experience in global teams and interdisciplinary environments.

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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).

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