GlaxoSmithKline Hiring for Senior Director/ Head of Respiratory Vaccines Clinical Statistics at Rockville, MD  Full Time

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.

Head of Respiratory Vaccines Clinical Statistics role has portfolio leadership for statisticians aligned to vaccine development in the area of Respiratory disease, providing statistical leadership for Clinical Development and Commercialization.

Key Responsibilities:

In this rewarding and visible role, the Head of Respiratory Vaccines Clinical Statistics responsibilities are

• To provide global leadership of statistical input across a business area’s portfolio, ensuring best-in-class integrated evidence strategies including study and development-plan design with high-quality analysis and interpretation.

• To ensure quantitative decision-making is embedded across R&D. Provides technical leadership and organisational influence in support of optimised development plans and decision-making frameworks.

• To provide statistical leadership in relation to post-submission activities and lifecycle management.

• Accountable for statistical sign-off on all aspects of a business-area’s portfolio, partnering closely with the overall Head of Vaccines Statistics as projects approach R&D governance milestones.

• To develop the capability of the broader Biostatistics and R&D organisations at GSK, promoting and fostering a culture for technical innovation and statistical best-practice.

• To influence effectively cross-functionally and externally (e.g. clinical, regulatory, commercial, health outcomes, RWE epi interventional studies, pharmaco-vigilance, business development) to ensure strategies are aligned and optimized.

• Partners with counterparts in the Programming organisation to ensure high-quality execution of all trial analyses and submissions, planning the resource strategy, with accountability for budget, quality and CRO oversight.

• Governance – playing a leadership role in ensuring Biostatistics SOPs meet current regulatory expectations and are fit for purpose.

• 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 and vaccines landscapes.

• Proven record of being able to influence internal and external stakeholders on challenging vaccine development and product-stewardship issues.

• 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.

• Extensive years of experience in the pharmaceutical industry.

• Vast experience supporting Vaccine development through commercialization from a statistical perspective.

• Strong Expertise in a range of statistical methodologies with application to real problems (of specific interest: Bayesian methods, complex clinical trial designs and statistical modelling)

• Strong knowledge of vaccine development strategies and processes formed by deep development experience. Will have supported a number of disease areas and/or have supported all phases of vaccine development in highly accountable roles.

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

Preferred Qualifications

• PhD in Statistics or closely related field.

• Ability to drive and influence strategic direction.

• Exceptional capability to influence leadership.

• Familiarity with regulatory interactions and pathways.

• Adept at:

– Embedding talent management throughout the team

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

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

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

– Examples of applying innovative statistical thinking.

– Ability to foster a strong collaborative spirit internally and externally.

• Strong business awareness and In-depth understanding across vaccines development phases.

• 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