Principal Biostatistician

**Southern Star Research** is a leading Australian, privately owned CRO based 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 Principal Biostatistician 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 Head, Biometrics, you’ll be responsible for:

- Provide Statistical input into protocol design, pharmacokinetics, sample size estimations, key efficacy and safety parameters and endpoints, randomization and blinding, statistical methods, and presentation of data and results (TLGs) for the specific project;
- Perform pharmacokinetic (PK), pharmacodynamics (PD) and biostatistical analyses using validated software and internal procedures;
- Work with internal stakeholders to create the statistical/clinical study report;
- Ensure programmes are properly documented and validated;
- Assist with project budgets and BD activities for biostatistics including TLG estimates and participation in client meetings and bid defence meetings;
- Contribute to Standard Operating Procedure review and development of new procedures and processes.
- Familiarity with CDISC and Biometrics related Guidelines; and
- Perform additional duties as required.
- Masters or PhD in Statistics/Biostatistics;
- A successful track record as a Principal Statistician or currently leading a Statistics team within a regulatory clinical trial environment;
- Ideally a minimum of eight to ten years’ experience as a Biostatistician in a CRO or Pharmaceutical Company;
- Excellent SAS programming skills;
- A good working knowledge of ICH-GCP, GCDMP;
- The ability to work well in a project team, adaptable and flexible;
- Provide a high level of service to both internal and external customers;
- High level of written, verbal, interpersonal and engagement skills.

**Why Southern Star Research?**

Southern Star Research is a growing a business and this is an ideal opportunity for someone who is looking to progress their statistical career in Phase I to IV trials in Australia. You will be a key member of a highly professional team who are focused in getting new drugs to market and providing high standards of customer satisfaction to clients_._

**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;
- Career stability and security;
- 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

**We’d love to connect with you**

Don’t have the 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.