Southern Star Research is a leading Australian, privately owned CRO headquartered in Sydney. We specialise in providing clinical research services to a range of clients across the pharmaceutical, medical device and biotechnology markets in Australia and New Zealand.
We recognise that attracting and retaining excellent staff is the key to developing a high quality CRO and providing our Customers with the best service possible. We greatly value the contributions our staff make to our clients’ projects and to the Company. Southern Star Research’s culture is focused on fostering and maintaining a positive, professional and productive work environment.
Due to continued growth and a strong project pipeline, we’re looking for a talented Senior Statistician to join our team in Australia.
If you’re interested in joining an innovative, exciting, Australian owned CRO, we’d love to talk to you.
About the Role
Reporting to the Manager, Statistics you will be responsible for:
* Leading the statistical aspects of clinical trials, including protocol design, sample size estimation, and endpoint development;
* Developing Statistical Analysis Plans (SAP) and defining statistical methodologies and procedures;
* Performing SAS programming and ensuring statistical outputs are accurate and well-presented;
* Reviewing and quality-controlling statistical results produced by programmers;
* Collaborating with team members, including Medical Writers and Project Managers, to create clinical study reports;
* Ensuring proper documentation and validation of computer programs used for analysis;
* Contributing to the design and review of CRF formats and supporting Data Monitoring Committees (DMCs);
* Identifying operational or quality issues and proposing solutions;
* Contributing to SOPs and process documentation;
* Familiarity with CDISC and Biometrics guidelines, and ensuring compliance with corporate systems;
* Perform additional duties as assigned.
To be successful in the role, we’re looking for candidates with:
* Appropriate tertiary qualifications in the medical, pharmaceutical or healthcare disciplines;
* A minimum of 5 years’ experience in biostatistics in a CRO or Pharmaceutical Company;
* 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;
* A good working knowledge of ICH-GCP, GCDMP, CDISC and Biometrics related guidelines;
* Demonstrate well-developed computer literacy skills preferably in SAS;
* A demonstrated ability to work well in a team, be adaptable and flexible, with a positive attitude and a willingness to learn;
* Superior organisation and planning skills and the ability to deliver work according to study timelines and within the project budget;
* A high level of written and verbal communication skills;
* An exceptional level of attention to detail.
Why Southern Star Research?
Southern Star Research is a growing business and this is an ideal opportunity for someone who is looking to progress their statistical skills in Australia. Southern Star Research are also proud to be certified as a Great Place To Work in Australia!
We offer –
* An attractive remuneration and benefits package;
* Genuine work-life balance (we appreciate you have hobbies, family and a personal life outside work);
* We value flexibility, and we welcome a discussion on what might work for you to meet your work/life commitments and support your wellbeing;
* Solid career pathways and progression in a growing company;
* Career stability and security;
* Head Office located in Gordon, Sydney – Under cover parking provided and close to public transport;
* STAR day – one extra day off per year to recharge; and more!
We’d love to connect with you!
Don’t have all the requirements of this role, but still interested? Please still apply!
Inclusivity, Diversity and Equality
Our commitment is to create a safe and inclusive environment that celebrates the diversity of our employees with their diverse perspectives, backgrounds and cultures.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
Please note that only successful candidates will be contacted.
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