Posted: 23 September 2024
The Company
Our client is a leading Australian-owned Clinical Research Organisation specialising in end-to-end services for clinical trial design and execution. In addition to their clinical and regulatory affairs service offerings, they also have in-house biostatistics experts who translate data into meaningful insights for their clients. These include global partners in the biotechnology, pharmaceutical, and medical devices industries, across a range of therapeutic areas and stages of clinical research.
The Opportunity
As a Principal Biostatistician, you’ll work closely with the Head of Biostatistics to work on a diverse range of statistics projects. Your work will include designing, implementing, and analysing clinical trials, ensuring scientific rigor, regulatory compliance, and data integrity. You’ll collaborate closely with cross-functional teams, including clinical operations, medical affairs, and regulatory affairs. This will include:
- Providing technical and operational guidance and execution statistics projects and delivering technical expertise to colleagues, clients, and external and internal stakeholders as required.
- Executing work assignments related to studies and projects, ensuring all work completed is compliant with relevant regulatory and quality requirements.
- Contributing to the execution of Statistics projects in line with the company’s Standard Operating Procedures and other processes collaborating with clients, internal and external stakeholders.
- Providing experienced input into the statistical sections of protocols, including recommendations for study design and sample size calculations, as well as the statistical analysis, validation and reporting of study data.
Position Requirements
- Excellent communication skills and a strong understanding of the importance of high-quality customer service delivery withing the CRO industry.
- Minimum Masters in Biostatistics, Biometrics, or other related discipline.
- At least six years of experience working as a biostatistician, ideally in the CRO industry or a related field.
- Proven ability to effectively and efficiently lead technical teams within a multidisciplinary organisation.
- Expert knowledge of statistics applicable to clinical trials and research data complemented by strong technical skills in statistical analysis, process, and programming processes.
- High-level knowledge of GCP regulatory environment of statistics and CDISC.
The Offer
This is an exciting opportunity to join a company with an exceptional company culture. They offer flexibility to employees, and devote significant resources to ensuring staff are engaged, successful, happy, and have their life/work balance right. To learn more, please email any questions you may have to careers@mexec.com or call 1300 063 932 to arrange a confidential discussion with Mark Thomas or Marilyn Jones.
Please note that our client is based in Melbourne but is open to remote working arrangements.
