Principal Pharmacokineticist

We’re Avance Clinical a Contract Research Organisation. We offer specialised services supporting drug development for the pharmaceutical and biotechnology industry. We have a rich history in this area with our founding roots dating back to the 1980’s. If you already work in this industry you’ll know that we are experts in our field and you’ll recognise that we’re a growing organisation.

**Why should you join Avance Clinical?**
We appreciate that our most important asset is our people. We offer a fun, friendly work environment and a culture that values honesty and respect. We have a strong sense of team. We genuinely appreciate each individual but recognise the collective when achieving success.

We are committed to creating a flexible work environment for our people by supporting them to balance their work commitments and personal needs, both now and into the future.

**The Opportunity**
If you are an experienced Pharmacokineticist who's passionate about clinical research and wants to work in a challenging, stimulating, and supportive environment where what you do matters, then we want to hear from you now.

**Broad Purpose**
The Pharmacokineticist is responsible for contributing expertise in pharmacokinetic and statistical design, analysis, and reporting of clinical studies.

**Core Responsibilities**
- Client liaison for any pharmacokinetic (PK), statistics or study design related issues.
- Develop and review study protocols.
- Prepare PK analysis plans and statistical analysis plans.
- Perform PK analyses using WinNonlin and perform statistical analyses.
- Perform non parametric PK modelling using WinNonlin.
- Prepare tables and figures of PK analysis results.
- Perform statistical analyses of study data other than PK data.
- Prepare tables and figures of study data other than PK data.
- Prepare randomisation schedules.
- Prepare PK reports and PK sections of clinical study reports.
- Liaise with bio-analytical laboratories regarding data transfer.
- Mentor role for Clinical Project Managers and Clinical Data Associates for development of understanding of pharmacokinetics and statistics.
- Other duties as directed by Line Management or delegate.

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**Qualifications, Skills and Experience**
- Bachelor’s degree or higher with an emphasis in pharmacokinetics/pharmacology, life sciences, medical/pharmaceutical sciences and/or statistics.
- Minimum of 10 years statistical analysis and/or pharmacokinetics experience.
- Minimum 10 years experience in the pharmaceutical industry / Contract Research Organisation (CRO) working in a GCP environment.
- Minimum of 3 years experience in tertiary education and/or equivalent mentoring
- Formal GCP training and experience with regulatory filing of PK statistics.
- Experience in clinical or pharmacological research with a focus in a technical writing environment.
- Proven experience with WinNonlin and SAS together with advanced skills in MS Word and MS Excel.
- Ability to communicate with clients, senior management and other stakeholders.
- Excellent oral and written communications skills including the ability to prepare reports and procedures.
- Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.
- Ability to work under pressure in a multi-disciplinary team environment.
- Commercial links with pharmaceutical and biotechnology industry _(desirable)._

**What we offer**
- Stimulating work
- Project diversity
- An intellectual challenge
- An agile & flexible workplace
- Opportunity to progress
- Stability
- Sense of community
- A leadership team that are working together on a common goal
- Flexible work options
- Great tools / tech to do your job
- A competitive salary & an extra days holiday for your birthday

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**What next?**
As a growing business we’re looking for likeminded people to join us - we hope that’s you.
- To join our team please submit your CV & cover letter as one Microsoft Word document
- You must have full Australian working rights to be considered
- At Avance difference is encouraged, its celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality._