Clinical/Medical Research (Healthcare & Medical)Full timeWe'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 1980s. 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 and genuinely appreciate each individual while recognising 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.The OpportunityIf you are an experienced Pharmacokineticist who is 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 PurposeThe Pharmacokineticist is responsible for contributing expertise in pharmacokinetic and statistical design, analysis, and reporting of clinical studies.Core ResponsibilitiesClient 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.Qualifications, Skills and ExperienceBachelor's degree or higher with an emphasis in pharmacokinetics/pharmacology, life sciences, medical/pharmaceutical sciences and/or statistics.Minimum of 5 years statistical analysis and/or pharmacokinetics experience.Minimum 5 years experience in the pharmaceutical industry / Contract Research Organisation (CRO) working in a GCP environment.Formal GCP training and experience with regulatory filing of PK statistics.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.What we offerStimulating workProject diversityAn intellectual challengeAn agile & flexible workplaceOpportunity to progressStabilitySense of communityA leadership team that is working together on a common goalFlexible work optionsGreat tools/tech to do your jobA competitive salary & an extra day of holiday for your birthday!What next?As a growing business, we're looking for like-minded 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.Alternatively, you could pick up the phone and call ****** Avance, difference is encouraged, it's celebrated and it's something we strive for. We empower cultural, disability, LGBTI+, and gender equality.
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