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For Companies At a Glance
- Tasks: Lead statistical analyses and provide expertise for clinical development projects.
- Company: Join a dynamic organisation focused on innovative medical solutions.
- Benefits: Enjoy flexible working options and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while collaborating with top professionals.
- Qualifications: Advanced degree in statistics or related field; experience in clinical trials preferred.
- Other info: Opportunity to attend conferences and enhance your statistical skills.
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.
- 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 (such as Investigators Meetings, Regulatory Agencies, Advisory Boards).
- Provides adequate and qualified statistical and methodological support to EPD, e.g. 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 ensure appropriate conduct of statistical analysis of EPD Clinical Development studies, which entails review of the statistical analysis plan, participation in Blind Data Reviews, and review of study report tables, listings, and figures.
- 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 to ensure the correct interpretation of the results by different users.
- Supports dossier submissions and answers statistical questions related to the file.
- For the purpose of integrated analyses of internal compound databases that are accumulating, writes the strategic and more detailed integration plans in cooperation with Clinical and ensures proper execution.
- Fully exploits the potential of the data to enhance the knowledge of the compound through data integration and data utilization activities (meta-analyses, data explorations).
- Manages external study statisticians working on the analysis of EPD clinical trial data.
- Briefs CROs on methodological and statistical deliverables.
- Reviews statistical literature and attends conferences and courses to ensure a high level of 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 relevant 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 can set you apart from other candidates and demonstrate your readiness for the role.
✨Tip Number 3
Prepare to discuss your experience with managing projects across multiple therapeutic areas. Be ready to provide examples of how you've successfully coordinated statistical analyses and collaborated with CROs in previous roles.
✨Tip Number 4
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.
We think you need these skills to ace Director Biostatistician
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in biostatistics, clinical development, and project management. Emphasise any previous roles where you coordinated statistical analyses or worked with CROs.
Craft a Strong Cover Letter: In your cover letter, clearly articulate your understanding of the role's responsibilities. Mention specific experiences that demonstrate your ability to manage multiple projects and provide statistical expertise in clinical settings.
Showcase Your Methodological Knowledge: Include examples of how you've applied statistical methodologies in past projects. Discuss your experience with endpoint definitions, sample size determination, and any contributions to clinical study protocols.
Highlight Communication Skills: Since the role involves presenting at external meetings and collaborating with various stakeholders, emphasise your communication skills. Provide examples of how you've effectively communicated complex statistical concepts to non-statistical audiences.
How to prepare for a job interview at Tech Observer
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with statistical methodologies and analyses. Highlight specific projects where you provided statistical support, especially in clinical development or regulatory submissions.
✨Demonstrate Project Management Skills
Since the role involves managing multiple projects across various therapeutic areas, share examples of how you've successfully coordinated projects in the past. Discuss your approach to prioritising tasks and managing timelines.
✨Prepare for Technical Questions
Expect questions related to statistical analysis plans, sample size determination, and endpoint definitions. Brush up on these topics and be ready to explain your thought process and decision-making in previous roles.
✨Engage with Real-World Scenarios
During the interview, be ready to discuss how you would handle specific scenarios, such as briefing a CRO or interpreting complex data results. This will demonstrate your practical understanding of the role and your problem-solving skills.
