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Senior Director/Head of Respiratory Vaccines Clinical Statistics

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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

How to apply:

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