Expert Statistician in Clinical Research

2 days ago

Brisbane, Queensland, Australia beBeeBiostatistician Full time $200,000 - $250,000

Cochlear is seeking a highly skilled Senior Biostatistician to play a pivotal role in the global clinical study development process. The successful candidate will be responsible for designing studies, performing sample size calculations, supporting randomisation activities, and authorising statistical analysis plans (SAP). They will also contribute to analysing and reporting Cochlear-sponsored studies, spanning from protocol development to interim and final analyses.

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.
  • Collaborate with cross-functional teams to design robust studies and develop appropriate analysis methodologies.
  • Create accurate, efficient, and well-documented programs that translate CIP and SAP requirements into programmed outputs to meet reporting needs.
  • Provide timely and accurate 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 is an exceptional opportunity to work in a global headquarters environment, making critical decisions regarding the statistical aspects of evidence generation. The successful candidate will have the chance to collaborate cross-sectionally with stakeholders from various fields of expertise, contributing to the advancement of hearing solutions.

About You

To add value to this role, you'll need to demonstrate the following skills and experience:

Minimum Requirements:
  • Masters/Doctoral qualifications in Statistics or Mathematics.
  • A minimum of 5+ years (MS) or 3+ years (PhD) of related work experience as a study statistician.
  • A 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.
Ideal Qualifications:
  • Experience dealing with regulatory agencies globally.
  • Familiarity with CDISC standards and regulatory requirements.

We value diversity and welcome candidates from diverse backgrounds. Our company aims to create a culture that celebrates differences, enabling our people to realise their full potential.

Benefits and Opportunities:

As a Senior Biostatistician at Cochlear, you'll enjoy flexible working arrangements and opportunities for professional growth and development. We're open to discussing what flexibility means for you and ensuring it aligns with your needs.

Our Mission:

At Cochlear, we're dedicated to helping people hear and be heard. We aim to provide lifelong hearing experiences and access to innovative technologies. Collaborating with industry-leading networks, we strive to give people the best possible outcomes.

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