Cochlear has a newly created opportunity for a Senior Biostatistician to join the organization in a global capacity. The successful Senior Biostatistician will play an integral role in various stages of clinical study development including designing studies, performing sample size calculations, supporting randomisation activities and authorising statistical analysis plans (SAP). You will also play a crucial role in analysing and reporting Cochlear-sponsored studies, spanning from protocol development to interim and final analyses.
As a Senior Biostatistician, you will have the opportunity to provide statistical advice on global and regional clinical research initiatives and investigator-initiated research (IIR). You will serve as a key resource within the Global Clinical and Medical Affairs (GCMA) team, providing valuable guidance on all statistical matters.
Responsibilities include:
* 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).
* Collaborate with cross-functional teams to meet business goals in compliance with regulatory requirements, scientific integrity, and good clinical practice.
What makes this opportunity unique?
As the successful Senior Biostatistician, you will have the opportunity to work in Cochlear’s global headquarters making critical decisions regarding the statistical aspects of evidence generation.
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 with this innovative Australian company, 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.
Cochlear’s mission is to help people hear and be heard. As the global leader in implantable hearing solutions, Cochlear is dedicated to helping people with moderate to profound hearing loss experience a life full of hearing. We aim to give people the best lifelong hearing experience and access to innovative future technologies. We collaborate with the industry’s best clinical, research and support networks. That’s why more people choose Cochlear than any other hearing implant company. Learn and grow with us as we tackle the most complex challenges in helping more people to hear and experience life’s opportunities.
How we recognise your contribution
We want Cochlear to be a place where our people truly enjoy coming to work. Through our internal programs and employee benefits, we aim to create an environment where our people will feel valued and supported. Whether your focus is on continuous learning, professional development or simply finding an environment which enables you to thrive whilst balancing family or personal life commitments, then we have several programs in place to support you.
At Cochlear 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. 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.
About the company
Based in Sydney, Cochlear was formed in 1981 with finance from the Australian government to commercialise the implants pioneered by Dr Graeme Clark.
#J-18808-Ljbffr