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Statistician Professional

3 weeks ago

Sydney, New South Wales, Australia beBeeBiostatistician Full time $100,000 - $125,000
Senior Biostatistician Job Opportunity

Southern Star Research is a leading Contract Research Organisation headquartered in Sydney, specialising in delivering high-quality clinical research services to clients across the pharmaceutical, medical device, and biotechnology sectors throughout Australia, New Zealand, and the Asia-Pacific region.

We are seeking a Senior Biostatistician to join our team as part of our expanding operations. This role will be responsible for providing statistical input into protocol design, including sample size estimations, key efficacy and safety parameters, endpoints, randomisation, and blinding.

Main Responsibilities:

  • Providing statistical input into protocol design, including sample size estimations, key efficacy and safety parameters, endpoints, randomisation, and blinding.
  • Development of Statistical Analysis Plans (SAPs), detailing methodology, programming procedures, variable definitions, and presentation of data and results for assigned studies.
  • Provide mentoring and training support to less experienced biostatisticians as required.
  • SAS programming and related activities to support project deliverables, as required.
  • Review and QC of statistical outputs produced by Statistical Programmers, ensuring accuracy and clarity in Tables, Listings, and Figures.
  • Manage statistical service deliverables across assigned projects.
  • Collaborate effectively with Medical Writers, Project Managers, and other stakeholders to produce high-quality statistical/clinical study reports.
  • Ensure all analytical programmes are properly documented and validated.
  • Provide statistical input into the design and review of Case Report Form (CRF) formats.
  • Actively participate in project team meetings, investigator meetings, and maintain close liaison with Project Managers.
  • Support Data Monitoring Committees (DMCs), ensuring appropriate blinding is maintained.
  • Identify and address operational or quality issues, proposing effective solutions.
  • Contribute to the review and development of Standard Operating Procedures (SOPs), work instructions, and new processes.
Requirements
  • MSc degree or higher in a statistics-related field.
  • A minimum of 3 years' experience in biostatistics, ideally within a CRO environment.
  • Expert knowledge in biostatistics in clinical trials and the necessary skills to evaluate current programming and other processes, develop strategies for improvement, and execute on those strategies.

About Us:

We offer a dynamic and supportive work environment that promotes professional growth and development. Our team is committed to delivering high-quality services to our clients, and we are seeking like-minded individuals to join us in this endeavour.