Statistician, Medical Technology Development
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About the business and the role
LBT Improve Patient Outcomes by making healthcare more efficient.
We develop automated products that use Intelligent Imaging and Interpretative Software to improve healthcare delivery.
LBT Innovations Limited (ASX: LBT) improves patient outcomes by making healthcare more efficient. Based in Adelaide, South
Australia, the Company has two world class-leading products in microbiology automation: MicroStreak®, which provides automated culture plate streaking and Automated Plate Assessment System (APAS®). Based on LBT’s intelligent imaging and interpretative software, US FDA-cleared APAS® automates imaging, analysis and interpretation of culture plates following incubation. LBT has entered into a joint venture, Clever Culture Systems AG (CCS) with Hettich AG Switzerland to commercialise APAS® products. LBT’s third product WoundVue® is in early development; this is a proposed automated solution to assist in the management of chronic wounds.
Job tasks and responsibilities
The Statistician for Medical Technology Development is responsible for applying robust statistical theories and methods to support bringing technology to market. This role must work closely with cross functional teams to understand the regulatory, business and technology context required to statistically support the product claims of the technology. Providing leadership in deciding what data is required to answer specific questions, along with performing the actual analysis and presentation of complex data is critical to the success of this role.
Job tasks and responsibilities include:
- In collaboration with functional teams, develop a comprehensive data capture and analysis methodology to support the effective routine capture of information that facilitates efficient analysis;
- Setup systems and process to ensure efficiency of statistical analysis with a goal that this becomes a core capability of LBT;
- Provide input into engineering and clinical design protocols that ensure statistical rigour is embedded in the process so that relevant data can be presented to a variety of stakeholders such as Regulators and Auditors;
- Bring expert knowledge of statistical theory to design: laboratory experiments for product development and testing, clinical studies and customer surveys or opinion polls, and any other applications that require statistical theory to be applied within the LBT business;
- Perform data analysis, using various statistical tools, interpret the results with understanding of the business intent, and write reports which meet the needs of the customer(s);
- A particular focus is on developing documentation to support submissions to regulators throughout the world. This will involve, but not limited to:
o Perform statistical modelling to decide study design;
o Prepare statistical analysis section of study protocol;
o Discuss protocol with regulators as required;
o Contribute to management of clinical research organisation (CRO) to:
– Prepare statistical analysis plan (SAP)
– Prepare data management plan (DMP) [set up & validate data collection tool; host and manage databases, generate and manages data queries, lock database, perform analysis to SAP, prepare line data, prepare analysis report] – Write final study report.
- Critical thinking with an ability to keep an open mind to understand the business context and apply statistical methodology to support business and technology outcomes.
Skills and experience
- Tertiary qualifications in statistics or mathematics; PhD would be highly regarded;
- Critical thinking – use logic and reasoning to identify strengths and weaknesses of potential solutions, conclusions or approaches to problems;
- Math skills – ability to use statistics, calculus and linear algebra to develop models and analyses;
- Programming skills – Expert use of specialised statistical software;
- Ability to program custom analyses as required;
- Problem solving – overcome problems in data collection and analysis;
- Communication skills – ability to present statistical concepts and information so that others can understand;
- Writing skills – report writing to explain technical matters to people without their level of expertise;
- An understanding of quality systems and regulatory requirements (e.g. FDA, TGA, CE, ISO13485, ISO 9000);
- Ability to work collaboratively with cross-functional teams