We are seeking a Biostatistician Expert to join our global team in a key role. As a senior statistician, you will be responsible for various aspects of clinical study development, including designing studies, performing sample size calculations, and authorising statistical analysis plans.
You will play a crucial role in analysing and reporting Cochlear-sponsored studies, from protocol development to interim and final analyses. Your expertise will be utilised in providing statistical advice on global and regional clinical research initiatives and investigator-initiated research.
Key Responsibilities:
* Author the statistical section of the Clinical Investigation Plan (CIP), perform sample size and power calculations, produce and review randomisation schemes where applicable.
* Work with cross-regional project teams to design robust studies and with appropriate analysis methodologies.
* Create accurate, efficient, and well-documented programs that translate the CIP and SAP requirements to programmed outputs to meet reporting requirements.
* Responsible for the accurate and timely statistical input to Independent Data Monitoring Committee (IDMC) and interim analyses reports.
* Evaluate the statistical validity of proposed analyses for a given dataset, and propose alternative strategies that are more robust, where appropriate.
* Review and provide feedback on the Clinical Investigation Report (CIR).
This opportunity offers significant personal growth and development, as you will collaborate with stakeholders from various fields of expertise. By contributing your expertise to the advancement of hearing solutions, you will make a positive difference in the lives of individuals with hearing impairment.
About You
To succeed in this role, you will need to demonstrate the following skills and experience:
Minimum Requirements:
* Masters/Doctoral qualifications in Statistics or Mathematics.
* At least 5+ years of related work experience as a study statistician.
* Thorough understanding of clinical trials methodologies and data management principles for clinical trials and medical research.
* Applied knowledge of advanced statistical methods, such as generalised linear models, survival analyses, mixed models.
* Strong programming skills in SAS and/or R.
* Excellent interpersonal and communication skills with a high level of proficiency in English.
We welcome applications from experienced professionals who share our passion for helping people hear and be heard.