Senior Biostatistician

Southern Star Research is a leading, privately owned Australian Contract Research Organisation (CRO) headquartered in Sydney. We specialise 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 understand that attracting and retaining exceptional talent is fundamental to building a world-class CRO and providing our clients with exceptional service. We deeply value the contributions our team members make to both our clients' projects and the success of our company.

At Southern Star Research, our culture is centred on fostering a positive, professional, and collaborative working environment. We are committed to supporting our staff and creating opportunities for growth, development, and meaningful impact.

If you're interested in joining an innovative, exciting, Australian owned CRO, we'd love to talk to you.

Reporting to the Manager, Statistics, you'll be responsible for:

• 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 (TLGs) 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.

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

• 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.

Southern Star Research is a growing business within the Asia Pacific region, and this is an ideal opportunity for someone who is looking to progress their SAS Programming skills by being involved in all aspects of programming across a range of different therapeutic areas. Southern Star Research are also proud to be certified as a Great Place To Work in Australia

• 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 you to recharge.

At Southern Star Research, we are 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 are 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.

Southern Star Research is trusted CRO offering world-class, high quality full-service clinical trails across the Asia Pacific region.