Senior Statistician - Biopharma R & D

Site Name: USA - Massachusetts - Boston
Posted Date: Apr 3 2023

Vaccines CMC Statistics team

When it comes to developing the Vaccines of the future, we’re looking for real experts who are interested in working in the stimulating environment of an international healthcare company.

If you have strong ambition, solid technical skills and passion for innovation and global-working, and you want to make a difference to patients’ lives then YOU could be the future of GSK Vaccines business.

As a Senior Statistician, you’ll join a global team of CMC statistics experts to bring all aspects of non-clinical statistics in Technical Research & Development during product, process and analytical development, regulatory approval, technical transfer of new Vaccines.

You’ll be an essential and accountable partner of technical project teams, management and key stakeholders in the organization in providing statistical expertise. You’ll apply fit-for-purpose, advanced and state-of-the-art statistical principles in a wide variety of situations.

You’ll influence internally and externally to adopt rigorous and sound statistical approaches which have large organizational, strategic and business impact.

Your responsibilities:

• You provide statistical expertise for all global development in compliance with current ICH / FDA, QbD guidelines and SOPs
• 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 stay up to date with latest developments in the field of statistics and explore CMC applications for our organization
• You act as essential partner for project technical teams (e.g. Technical Development Leader, functions representatives, …) or other stakeholder groups and provide statistical expertise in all aspects of Technical Research & Development (Product, Process and Analytical Development and commercialisation) bringing the added value of data-driven decisions.
• You ensure high quality regulatory dossiers which set the benchmark in the industry and result in high regulatory acceptance.
• You master a broad range of statistical sciences applications, such as linear model, DOE, sample size, multivariate analysis, modelling, simulation, machine learning, … with knowledge of statistical and programming software (e.g. SAS, R, JMP, Python, …).
• You upskill the organisation on the application of statistics by providing training.
• 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 ensure 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 the development of product (e.g. stability modelling), process (e.g. modelling and simulation of biopharmaceutical process) and analytical methods (e.g. bioassays development) to ensure competitive and state of the art quality and productivity.

Why you?

Basic Qualifications:

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

• 7 years relevant work experience in applying statistics within industry, preferably pharmaceutical environment
• Master's or PhD in Data Science, Statistics, Mathematics, or related field

Preferred Qualifications:

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

• Experience in cross-functional teams
• Continuous learning and entrepreneurial mindset to support implementation of GSK’s digital strategy
• Strong communication, collaboration and influencing skills
• Ideally experience in Quality by Design as applied to biologics and vaccines
• Ideally knowledge of vaccines industry, especially in the development, approval and commercialization of vaccine products
• Experience of working in global and agile cultural teams

#LI-GSK

Why GSK?

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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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