CMC Lead Statistician

Responsibilities:

• You act as essential partner for project technical teams (e.g. Technical Development Leader, functions heads and representatives, ...) or other stakeholder groups and provide statistical expertise in all aspects of Technical Research & Development (Product, Process and Analytical Development and commercialization) bringing the added value of data-driven decisions.
• You lead the full integration of statistics across functions into everyday work as appropriate based on a close and deep partnership with scientists. You ensure advanced statistical concepts are routinely being applied during product, process and analytical development to ensure competitive and state of the art quality and productivity.
• You take full ownership and accountability of all statistical content in a QbD framework. Typical applications include the establishment of experimental strategies and the evaluation of experimental results for process / analytical method development and validation, technical transfers, critical investigations etc.
• You master a broad range of statistical sciences applications, such as linear model, DOE, sample size, multivariate analysis, modelling, machine learning, ... with knowledge of statistical and programming software (e.g. SAS, R, JMP, Python, ...).
• You focus on development of associates and contribute to build a high performing team that has large positive impact on the organization. You help the TRD Statistics Manager in coaching and development of less experienced team members.
• You upskill the organisation on the application of statistics by providing training.
• You ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
• You manage external and internal collaborations with statistical thought leaders and statistical groups in other functions and divisions. You influence GSK internal policies, guidelines and Standard Operating Procedures (SOPs) to ensure appropriate statistical application and represent the organization on key conferences and advocacy groups in order to influence the external and regulatory environment.
• You lead global strategic projects requiring a statistical solution to fulfil regulatory requirements.
• You stay up to date with latest developments in the field of statistics and explore, develop and test new CMC applications for our organization.

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

• University degree (Master / PhD) in Statistics, Mathematics, Data Science or related field
• Ideally > 10 years of relevant work experience in applying statistics within industry, preferably pharmaceutical environment
• Fluent English required; second language desirable (e.g. Italian, French)

If you have the following characteristics, it would be a plus:

• Experience of working in global and agile cultural teams
• Experience in cross-functional teams
• Ideally significant experience in Quality by Design as applied to biologics and vaccines
• Ideally broad knowledge of vaccines industry, especially in the development, approval and commercialization of vaccine products
• Strong communication, collaboration and influencing skills
• Ideally experience and personal interaction with Health Authorities such as FDA, EMA etc
• Continuous learning and entrepreneurial mindset to support implementation of GSK's digital strategy