Biostatistics Team Lead

Cambridge, UK

Owlstone Medical’s mission is to save 100,000 lives and save health care providers $1.5B, with several major projects underway to develop disease screening and diagnostics based on detection of volatile metabolic products on breath.

We are currently seeking a Biostatistics Team Lead for our Clinical and Translational Science Department. The ideal candidate will be the subject matter expert (SME) in biostatistics and will advance the scientific mission of the company by providing critical input and statistical oversight of research plans, trial protocols, research study designs, data analyses and project reports. As Team Lead, you will ensure the scientific integrity and operational efficiency of a highly engaged and effective Biostatistics Team, and mentor and facilitate their personal and career development. You will oversee and contribute to strategic initiatives for the Biostatistics Team and promote consistent approaches to statistical experimental design and data investigation that meet the desired study intentions.

The key responsibilities of the role are:

Technical Leadership

  • Being a centre of expertise who provides statistically sound methodologies that support the continuum of efforts from biomarker discovery through clinical test development
  • Developing the statistical analysis pipeline for experimental and clinical data, including significance testing, modeling, simulation, machine learning, and network analysis
  • Communicating effectively to non-statisticians the value of rigorous statistical methods to answer questions, predict outcomes, and support decision making
  • Conducting technical review and internal training in the department's core areas of expertise
  • Providing statistical leadership and input to the development of IRB/ethics and regulatory documentation, regulatory interactions, and responses to health authority submissions

Team Leadership and Management

  • Setting and maintaining clear expectations and purpose for the team and the individuals, ensuring each team member plays their part in delivering the company Objectives
  • Ensuring the team has the capability and capacity to support the company Objectives
  • Empowering and motivating the team to work effectively, embrace change and reach its full potential
  • Creating a coaching culture in the team where constructive, timely feedback, active listening and employee wellbeing are supported
  • Managing performance through regular measurement, communication and appropriate corrective action to ensure that you have a high-performing and engaged team
  • Being a role model for the Owlstone Culture and Values

Accountabilities

  • Supporting the Sales and Marketing Teams by providing expert statistical advice on client protocol design and project deliverables during project scoping/contracting stages
  • Providing input, authoring, or approving the Statistical Analysis Plan (SAP) for external customers and internal studies
  • Acting as the point of contact for customers wishing to discuss analysis plans and study outputs
  • Supporting project report writing and review, including input on statistical significance of findings and suggestions for sound validation of results in the form of follow-on projects
  • Providing statistical input into biochemical pathway analysis projects that integrate multiple biological and/or clinical datasets (e.g., proteomics, transcriptomics, volatolomics) generated through biomarker discovery projects
  • Maintaining technical knowledge and skills appropriate for the role, including staying current with innovative statistical methodologies in clinical trial design and analysis

Requirements

Essential

  • An expert understanding of biostatistics methods (power/sample size analysis, hypothesis testing, parametric, non-parametric, multivariate statistical tests, covariate analyses) and tools (R or other statistical packages), and their application to clinical trial-based datasets
  • An aptitude for and strong interest in leading, managing and developing biostatisticians at a range of career stages
  • Ability to communicate complex statistical knowledge verbally and in writing to specialists and non-specialists alike
  • Demonstrated ability to take initiative, think and work independently, problem-solve, work in multi-disciplinary teams and multi-task
  • Proactive in your approach to work, with an independent, creative and open mindset
  • Excellent interpersonal and communication skills, with capability in building and maintaining strong working relationships

Desirable

  • Able to demonstrate a track record of leading and managing high-performing teams, preferably in industry, and preparing statistical deliverables on schedule
  • Statistical experience working with CROs and the biopharmaceutical industry
  • Knowledge of targeted and non-targeted biomarker discovery
  • Experience working with mass spectroscopy-based metabolomics (or other omics) data derived from clinical trial or epidemiology/cohort studies
  • Experience working closely with clinical biologists and translational scientists to analyze and interpret clinical datasets
  • Experience designing in-human trials for pharmaceutical products and/or biomarker studies
  • Previous experience working with business development and presenting proposals to customers and/or senior management

Qualifications

  • PhD (or Master's degree) in statistics or a related discipline with demonstrable experience performing statistical analyses in a regulated environment (preferably medically-related) or fast-paced commercial operation
  • Strong publication record preferred.

Benefits

About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk.


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