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- Tasks: Lead statistical analyses and provide expertise for clinical development projects.
- Company: Join a dynamic organisation focused on innovative healthcare solutions.
- Benefits: Enjoy flexible working options, professional development opportunities, and a collaborative culture.
- Why this job: Make a real impact in healthcare while working with cutting-edge data and methodologies.
- Qualifications: Advanced degree in statistics or related field; experience in clinical trials preferred.
- Other info: Opportunity to attend conferences and enhance your statistical expertise.
The predicted salary is between 54000 - 84000 £ per year.
Job responsibilities (but not limited to):
Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses. In this matter supports both the Clinical Development portfolio as well as Strategic Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and policies and standards. Directs the operational aspects of
statistical work as outsourced to CROs.
Manages several projects and works in more than one therapeutic area.
Attends and presents at external meetings for Statistics (as Investigators Meetings, Regulatory Agencies, Advisory Boards).
Provides adequate and qualified statistical and methodological support to EPD, eg input into Clinical Development Plans, and study protocols. Responsible for appropriate statistical methodology and endpoint definitions as part of the design of clinical studies and for the associated sample size determination. Writes and/or reviews the statistical part of the protocol.
Responsible for briefing the CRO to an appropriate conduct of statistical analysis of EPD Clinical Development studies. This entails review of the statistical analysis plan, participation in Blind Data Reviews, review of study report tables,listings and figures. Incumbent approves the lock of the database and requests unblinding of the study for subsequent analysis. Together with the Clinician, clarifies and communicates the results and conclusions in order to
ensure the correct interpretation of the results by different users.
Supports dossier submissions and answers statistical questions related to the file.
For purpose of integrated analyses of internal compound data bases that are accumulating, incumbent writes the strategic and more detailed integration plans in co-operation with Clinical and ensures proper execution.
Fully exploits the potential of the data in order to enhance the knowledge of the compound through data integration and data utilization activities (meta-analyses, data explorations).
Manage external study statisticians working on the analysis of EPD clinical trial data. Briefs CRO\’s on methodological and statistical deliverables.
Reviews statistical literature and attends conferences and courses in order to ensure a high statistical expertise and maintain proficiency: Works with other statisticians to acquire knowledge on new/improved statistical methodology. Keeps up to date in relevant statistical expertise and clinical content expertise.
Director Biostatistician employer: Tech Observer
Contact Detail:
Tech Observer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director Biostatistician
✨Tip Number 1
Network with professionals in the biostatistics field, especially those who have experience in clinical development and regulatory affairs. Attend industry conferences and workshops to meet potential colleagues and learn about the latest trends and methodologies.
✨Tip Number 2
Familiarise yourself with the specific statistical software and tools commonly used in clinical trials. Being proficient in these tools can set you apart from other candidates and demonstrate your readiness for the role.
✨Tip Number 3
Stay updated on international regulatory guidelines and policies related to biostatistics. Understanding these regulations will not only help you in interviews but also show your commitment to compliance and quality in clinical research.
✨Tip Number 4
Prepare to discuss your experience managing projects across multiple therapeutic areas. Highlight specific examples where you successfully coordinated statistical analyses and collaborated with cross-functional teams, as this is crucial for the Director Biostatistician role.
We think you need these skills to ace Director Biostatistician
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Director Biostatistician. Familiarise yourself with the key tasks mentioned in the job description, such as statistical analysis, project management, and collaboration with CROs.
Tailor Your CV: Highlight your relevant experience in biostatistics, particularly in clinical development and strategic medical affairs. Emphasise your expertise in statistical methodologies and any experience managing projects across multiple therapeutic areas.
Craft a Compelling Cover Letter: In your cover letter, explain why you are a great fit for this role. Mention specific examples of how you've provided statistical support in previous positions, and how you’ve successfully communicated results to various stakeholders.
Showcase Continuous Learning: Mention any recent courses, conferences, or literature you’ve engaged with to stay updated on statistical methodologies. This demonstrates your commitment to maintaining high statistical expertise, which is crucial for the role.
How to prepare for a job interview at Tech Observer
✨Understand the Role Thoroughly
Make sure you have a deep understanding of the responsibilities outlined in the job description. Familiarise yourself with statistical methodologies, clinical development plans, and the role of CROs in biostatistics. This will help you answer questions confidently and demonstrate your expertise.
✨Prepare for Technical Questions
Expect to be asked about specific statistical methods and their applications in clinical trials. Brush up on your knowledge of sample size determination, endpoint definitions, and data integration techniques. Being able to discuss these topics in detail will showcase your technical proficiency.
✨Showcase Your Project Management Skills
Since the role involves managing multiple projects across different therapeutic areas, be prepared to discuss your experience in project management. Highlight any relevant examples where you successfully coordinated teams or managed timelines, especially in a clinical setting.
✨Demonstrate Communication Skills
As the position requires collaboration with clinicians and presenting at external meetings, it's crucial to exhibit strong communication skills. Prepare to discuss how you've effectively communicated complex statistical concepts to non-statistical audiences in the past.
