Job Description

GSK is a place where outstanding people do amazing things. As a science-led global healthcare company, we exist to help people do more, feel better, live longer. Our goal is to be one of the most innovative, best performing, and trusted healthcare companies. 

This is an exciting opportunity to channel your passion for innovation in the field of Statistics and Data Science to help shape the future of the Biostatistics function and transform the way in which GSK uses data and quantitative thinking to drive decision-making in R&D. 

Biostatistics is the single-largest functional group of Statisticians, Programmers and Data Scientists within GSK R&D, numbering approx. 800 permanent people in the US, UK, Europe and India. Our mission is to put statistical thinking at the heart of R&D decision-making; to ensure that predictive models and well-designed experiments and trials deliver robust evidence as the input to those decisions – ultimately making the R&D process more efficient and increasing the probability of success. 

Key Responsibilities: 

In this rewarding and visible role, the Global Head, CMC Statistics responsibilities are 

To provide global leadership of statistical input throughout CMC work in R&D, and to generate business value by driving the adoption of statistical best practice in CMC work within R&D

To develop an effective strategy to ensure that statistical thinking is at the heart of CMC decision-making 

Work with business partners to ensure statistical aspects of CMC related regulatory packages are of high quality 

Work with departments across MDS (Medicine Development & Supply, the home of CMC in pharma R&D) to harness statistical insight and expertise to reduce the risk of product manufacture problems 

To develop the capability of statistical sciences, and of the broader statistics organisation at GSK, promoting and fostering a culture of continuous improvement and self development 

Strong contributor to and member of the Research & MDS Statistics Leadership Team

Encouraged to represent GSK at external professional/ industry organization meetings and work on industry-wide issues (e.g., ICH working group). 

Develops innovative methodologies or strategies used across GSK and the industry with high business impact. 

To influence effectively cross-functionally and externally (e.g. vaccines CMC departments, manufacturing, regulators) to ensure strategies are aligned and optimized. 

To prioritize the work of statistical science staff and resources so as to maximize value for GSK 

To ensure their group’s compliance with GSK policies and procedures and that all aspects of their group’s conduct are aligned with GSK’s integrity principles. 

Job related Experience: 

Highly credible within the broader statistics community and with senior stakeholders across GSK, with strong knowledge of the statistical, regulatory landscapes within CMC space.

Able to operate effectively in a range of external settings, such as working with co-development partners, consulting with external experts or representing GSK at high-profile regulatory meetings. 

Basic Qualifications 

Master’s Degree in Statistics or a related field with applicable experience. 

Knowledge of CMC strategies and processes formed by previous statistical leadership of CMC projects is preferred 

Proven managerial skill and ability to lead global inter-disciplinary teams 

Strong record of statistical consultancy to scientists, and of influencing the course of scientific projects 

Highly credible within the broader statistics community and with senior stakeholders across GSK, with strong knowledge of the statistical, regulatory and scientific landscapes. 

Proven record of being able to influence senior internal and external stakeholders and to change statistical practices within business partners 

Preferred Qualifications 

PhD in Statistics or closely related field. 

Ability to drive and influence strategic direction. 

Exceptional capability to influence leadership. 

Ideally will have external statistical presence and at minimum will have good all-round knowledge of the broader statistical landscape as applied to non-clinical statistics. 

Familiarity with regulatory interactions and pathways. 

Adept at: 

o Embedding talent management throughout the team 

o Provide constructive feedback to enable team members to perform to their optimum 

o Create and lead an empowered, motivated team where diversity of thought is encouraged. 

o Demonstrated ability to lead or make major contributions to department, organizational and/or industry-wide initiatives, through effective communication and influence. 

o Examples of applying innovative statistical thinking. 

o Ability to foster a strong collaborative spirit internally and externally

Experience working independently with senior executives and the ability to quickly build personal credibility and assimilate business issues/need. 

Demonstrated skill operating in situations characterized by complexity, ambiguity and high levels of uncertainty.

*LI-GSK