We are seeking a highly skilled
Biostatistics Professional
to join our team in a global capacity. This is an excellent opportunity for someone who wants to play a crucial role in various stages of clinical study development, including designing studies, performing sample size calculations, supporting randomisation activities and authorising statistical analysis plans (SAP). The successful candidate will also have the opportunity to provide statistical advice on global and regional clinical research initiatives and investigator-initiated research (IIR).
About the Role
The
Senior Biostatistician
will serve as a key resource within our Global Clinical and Medical Affairs (GCMA) team, providing valuable guidance on all statistical matters.
Main 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 GCMA and 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).
Requirements
To add value to our organisation in this role, you'll be able to demonstrate the following skills and experience:
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.
Aplied 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.
About Us
We are a global leader in implantable hearing solutions dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. Our mission is to give people the best lifelong hearing experience and access to innovative future technologies.
Benefits
We offer flexible working arrangements, and we understand flexibility is not the same for everyone. We're open to a conversation about what flexibility means for you. At our organisation, we value and welcome the unique contributions, perspectives, experiences, and backgrounds of our employees and aim to build a culture that celebrates and leverages these differences, creating a sense of belonging and enabling our people to realise their full potential.