Head, Clinical Trial Methodology

Job Description

CAREER STEP: Expert

REPORTING RELATIONSHIP: Director, Biostatistics and Data Science Division

DIVISION: Biostatistics and Data Science Division

EMPLOYMENT DURATION: As per contract of employment 

TYPE OF EMPLOYMENT: As per contract of employment 

DATE: October 2024

About The George Institute

The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide, particularly underserved populations, by challenging the status quo and using innovative approaches to prevent and treat the world’s biggest killers: non-communicable diseases and injury. 

With offices in Australia, China, India and the UK, our 700+ people support 245+ active projects and clinical trials across 50+ countries, with 400+ more staff across our social enterprises. We focus on the global health challenges that cause the greatest loss of life, the greatest impairment of life quality and the most substantial economic burden, particularly in resource-poor settings. 

Together with our academic partners, UNSW Sydney in Australia, Manipal Academy of Higher Education in India and Imperial College London in the United Kingdom, we work with a global network of collaborators, undertaking clinical, population and health systems research. 

What we do

• Lead world-class, large-scale clinical trials, epidemiological studies and health systems research to transform treatments and healthcare delivery
• Look beyond single diseases, across the life course, to identify patient-centred approaches to care that can be implemented at scale
• Develop low-cost, innovative solutions to global unmet needs
• Drive our global impact through a program of research, advocacy, thought leadership and disruptive social entrepreneurship 

For more information about The George Institute, visit www.georgeinstitute.org. 

Context of the Role  

The Biostatistics and Data Science division is responsible for the provision of statistical expertise to support the research done at the George Institute. A strong focus is the design and analysis of clinical trials which underpin our global program of research. The Institute recently launched a Clinical Trial Innovation Hub to further develop its capacity in innovative trial design, efficient evidence-based conduct and cutting-edge analysis methods. 

The Role

The main aim of the role is to develop the use of innovative statistical methodology to support efficient and robust research practices. The role is global and cuts across all research programs. The main focus will be on clinical trial methodology including novel designs (e.g. adaptive designs) and innovative analytic methods.

The Head, Clinical Trial Methodology will be expected to spend approximately half her/his time conducting a program of methodological research and half on the design and analysis of projects initiated by research programs across the institute. The exact split is expected to vary depending on the amount funding obtained for the statistical research program. 

This position will potentially be eligible for a conjoint academic appointment at one of our affiliated universities e.g. the University of New South Wales or Imperial College London. 

Reporting Relationships

The Head Clinical Trial Methodology will directly report to the Director, Biostatistics and Data Science. Statistical research fellows and data scientists in the Clinical Trial Innovation hub will report to the Head, Clinical Trial Methodology. 

Duties and Key Responsibilities

• Coordinate a global program around clinical trial methodology
• Supervise research fellows and data scientists from the clinical trial innovation hub
• Provide expert advice to other members of The George Institute in appropriate statistical techniques
• Provide thought leadership and expertise on all aspects of clinical trial design, analysis and reporting
• Contribute to the development of study proposals and funding applications
• Design clinical trials including power calculations and simulations
• Lead the development of statistical analysis plans and perform complex statistical analyses
• Ensure delivery of statistical services to support Institute projects in accordance with pre-specified agreed targets and timelines
• Play a key role in the interpretation and publication of research results
• Engage in independent academic research (e.g. higher degree supervision)
• Obtain and manage funds to support the statistical research program (e.g. fellowship applications)
• Actively develop collaborations with peers locally and internationally
• Maintain currency of skills and knowledge by keeping abreast of current developments in biostatistics and statistical computing of relevance to clinical trials and medical research
• Lead global capacity development in biostatistics with a focus on clinical trial methodology
• Comply with all institute policies and SOPs as well as regulatory requirements for the programming, analysis and reporting of research projects (e.g. FDA, EMEA, TGA etc)
• As we are a global organisation, engage with colleagues and stakeholders in other regions relative to the responsibilities of the role, accommodating global time zones where required, to ensure seamless communication and collaboration. 

As a Team Member:

• Participate in special projects to improve processes, tools, systems and organisation;
• Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of The Institute’s Performance Management and Development Policy;
• Demonstrate commitment to The Institute’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts. 

Work, Health and Safety

• Comply with Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at the Institute;
• Promote and contribute to a safe, secure environment for staff and visitors. 

Skills, Knowledge and Experience

Essential

• Doctoral qualifications in Statistics
• Proven experience as a Senior Biostatistician in an academic/health setting or related field
• Demonstrated experience in conducting statistical research including refereed publications in statistical methodology
• Substantial experience in the design, analysis and reporting of clinical trials
• Excellent working knowledge of at least one of R (preferred), SAS or Stata software
• In-depth understanding of probability and statistics theory
• Understanding of data management principles for clinical trials and medical research
• Applied knowledge of advanced statistical models, such as generalized linear models, survival analyses and mixed models
• Experience managing projects, including project resourcing and planning
• Working knowledge of regulatory requirements for clinical trials and medical research
• Demonstrated managerial or team leadership experience and/or high leadership potential
• Strong focus on quality and timely delivery of work.
• Well organized with good time management skills
• Strong problem solving and analytical skills
• Excellent interpersonal skills with high level of proficiency in English
• Ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
• Ability to see the big picture, whilst still maintaining a focus on detail and implementation
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments
• Flexibility to work non-standard hours of work for collaboration and contact with global teams based on requirements of the position

Desirable

• Experience in the application of Bayesian methods
• Experience in the design of adaptive trials