Biostatistician Opportunity
Cochlear is a global leader in the development of hearing solutions, and we are seeking a highly skilled Senior Biostatistician to join our team. This role will play an integral part in various stages of clinical study development.
The successful candidate will have the opportunity to provide statistical advice on global and regional clinical research initiatives and investigator-initiated research (IIR). As a key resource within our Clinical and Medical Affairs team, you will provide valuable guidance on all statistical matters.
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-functional 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 role offers significant personal development opportunities as you will collaborate cross-sectionally with stakeholders from various fields of expertise. By contributing your expertise to the advancement of hearing solutions, you will be making a positive difference in the lives of individuals with hearing impairment.
About You
To add value to Cochlear in this role, you'll be able to demonstrate the following skills and experience:
Minimum:
* Masters/Doctoral qualifications in Statistics or Mathematics.
* Minimum 5+ (MS) or 3+ (PhD) 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, and similar.
* Strong programming skills in SAS and/or R.
* Excellent interpersonal and communication skills with a high level of proficiency in English; any additional major language is an asset.
* Strong problem-solving and analytical skills with the ability to see the impact of decisions in the larger context while remaining focused on the detail and implementation.
Ideal:
* Experience dealing with regulatory agencies/notified bodies globally.
* Familiar with CDISC standards and regulatory requirements.
* Familiar with handling large and disparate datasets, SQL and Python.