Clinical PK/PD Data Analyst – Breda, The Netherlands.
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and Europe-wide representation.
“Our vision is to deliver results of the highest quality to our global sponsors on time and within budget. We do this through developing our staff to be world class in their fields and forming real, lasting relationships with our clients.”
We are currently looking for a Clinical PK/PD Data Analyst to join the Clinical PKPB Team based in our office in Breda, Netherlands. Reporting to the Group Leader Clinical Pharmacokinetics, the successful candidate will be responsible for independently managing a diverse and complex range of non-compartmental (NCA) pharmacokinetic and pharmacodynamic analysis of a clinical trial. The role holder will support the consultants in clinical pharmacokinetics / clinical development.
If you are seeking a rewarding and challenging career this could be the perfect opportunity for you.
- Perform preliminary and final pharmacokinetic/pharmacodynamic non-compartmental analysis in line with the applicable ICH-GCP Guidelines, relevant SOPs, manuals and procedures including specific Sponsor requirements
- Write PK analysis plans and contribute to the review/development of data transfer agreements
- Perform statistical analysis on derived pharmacokinetic parameters
- Generate supporting tables and figures by means of SAS or other specific software
- Generate datasets containing the pharmacokinetic/pharmacodynamic results in line with CDISC standards
- Review and QC of pharmacokinetic/pharmacodynamic analysis and related output, including PK report, may also contribute to PK report writing under guidance of consultant
- Identify & participate in process improvements, develop & present solutions and perform operational trouble shooting
- Keep up to date with the expertise in the relevant areas and proactively identify opportunities to update and increase knowledge
- Provide training, mentoring and support to less experienced data analysts
- Contribute to the business development by generating high-quality output, delivered in a timely manner with clear communication
- Contribute to the success of the project through the successful delivery of the pharmacokinetic results within agreed timelines and budget
- Ensure high levels of customer satisfaction by focusing on efficiency and results and exceeding customer expectations on assigned work activities
- Execute tasks delegated by Consultant(s) ensuring to proactively communicate progress and status to the Consultant(s)
- Completion of additional tasks not specified herein as required by management to ensure successful/smooth business operations.
Qualifications & Experience:
- BSc or higher (MSc orPhD would be advantageous)
- A minimum of 3 years relevant work experience – depending on his/her competency and experience, a candidate with less experience may also be considered
- Proficiency in a programming language such as SAS
- Ability to work independently and as part of a team
- Results oriented with the ability to multi-task, with skill in establishing priorities, managing workload and meeting strict deadlines/timelines;
- Ability to anticipate potential issues and problems that may arise and proactively identify ways to resolve/mitigate;
- Independent analytical thinking, creativity and innovation and excellent attention to detail, planning & organisational skills;
- Ability to be flexible and to adapt and work effectively with a variety of situations or individuals
- Team worker with strong customer service and interpersonal skills, ability to communicate effectively and form positive relationships at all levels in and outside the company
- Professional who is experienced and dependable with discretion, enthusiasm and a positive attitude
- Good understanding of the pharmacokinetic principles and clinical development;
- Proficiency in usage of SAS and Phoenix WinNonlin
- Proficiency in PC skills required for Word, Excel, PowerPoint and Outlook
- Written and verbal communication skills including command of English
How to apply:
Please forward your CV (in English) by email to Liane Brown-Feaheny, email@example.com
We do not require the services of agencies for this role.