Senior Clinical Trials Statistician

Southern Star Research is a leading Contract Research Organisation (CRO) headquartered in Sydney. We deliver high-quality clinical research services to clients across various sectors throughout Australia, New Zealand, and the Asia-Pacific region.

We attract and retain exceptional talent by building a world-class CRO that provides clients with exceptional service. Our team members contribute significantly to our clients' projects and the company's success.

Our culture is centred on fostering a positive, professional, and collaborative working environment. We support our staff and create opportunities for growth, development, and meaningful impact.

If you're interested in joining an innovative and exciting business, we'd love to discuss this opportunity with you.

You'll report to the Manager, Statistics, and be responsible for:

• Providing statistical input into protocol design, including sample size estimations, key efficacy and safety parameters, endpoints, randomisation, and blinding.
• Developing Statistical Analysis Plans (SAPs), detailing methodology, programming procedures, variable definitions, and presentation of data and results for assigned studies.
• Providing mentoring and training support to less experienced biostatisticians as required.
• Engaging in SAS programming and related activities to support project deliverables.
• Reviewing and QC of statistical outputs produced by Statistical Programmers, ensuring accuracy and clarity in Tables, Listings, and Figures.
• Managing statistical service deliverables across assigned projects.
• Collaborating effectively with Medical Writers, Project Managers, and other stakeholders to produce high-quality statistical/clinical study reports.
• Ensuring all analytical programmes are properly documented and validated.
• Providing statistical input into the design and review of Case Report Form (CRF) formats.
• Actively participating in project team meetings, investigator meetings, and maintaining close liaison with Project Managers.
• Supporting Data Monitoring Committees (DMCs), ensuring appropriate blinding is maintained.
• Identifying and addressing operational or quality issues, proposing effective solutions.
• Contributing to the review and development of Standard Operating Procedures (SOPs), work instructions, and new processes.

To be successful in this role, we're looking for candidates with:

• A Master's 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.

This is an ideal position for someone who wants to progress their SAS Programming skills by being involved in all aspects of programming across a range of different therapeutic areas.

• A flexible work environment with hybrid and fully remote options.
• Ongoing opportunities for learning and development.
• Office located in Gordon – under cover parking provided and close to public transport.
• STAR day – one extra day off per year for personal recharge.

We're committed to fostering a safe, inclusive, and respectful workplace where everyone feels valued and empowered to contribute. We celebrate the diversity of our team and recognise the strength that comes from different perspectives, backgrounds, and lived experiences.

We're dedicated to ensuring an inclusive recruitment process and providing equal opportunities for all applicants, regardless of race, ethnicity, gender identity, sexual orientation, age, disability, or cultural background.