Senior Biostatistician

Overview

Senior Biostatistician - Sydney or home based anywhere in Australia. Join to apply for the Senior Biostatistician - Sydney or home based anywhere in Australia role at Southern Star Research.

About Us

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.

About The Role

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.

Qualifications

• 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.

Why Southern Star Research?

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

We Offer

• Competitive remuneration
• 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.

Diversity, Equity and Inclusion

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.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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