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- Tasks: Lead biostatistical projects and ensure quality analysis for clinical trials.
- Company: Nanosep AB is a global leader in clinical research, enhancing patient outcomes worldwide.
- Benefits: Enjoy remote work flexibility and a commitment to diversity and inclusion.
- Why this job: Join a mission-driven team impacting global health with innovative statistical methodologies.
- Qualifications: Masters or PhD in Biostatistics with 10+ years of relevant experience required.
- Other info: Ideal for those passionate about rare diseases and immunology.
The predicted salary is between 54000 - 84000 £ per year.
As an Associate Biostatistics Director, you will liaise with cross-functional teams to drive quality statistical planning, analysis, and reporting in support of pharmaceutical development and regulatory submissions. You will serve as a resource for the department, ensuring scientific integrity and regulatory compliance in applying statistical methodology to clinical trials.
Your responsibilities include leading major projects, contributing to clinical development plans, reviewing protocols, analysis plans, and reports, and responding to regulatory queries.
Key Responsibilities:- Serve as a biostatistical consultant for department members and staff from other Biostatistics departments.
- Represent sponsors at regulatory meetings and participate as a Data and Safety Monitoring Committee member.
- Engage in research activities, teaching, presentations, and manuscript preparation.
- Lead studies operationally and review statistical standards and validation procedures.
- Consult on operational, statistical, and therapeutic topics.
Maintain awareness of developments in biostatistics, clinical trial methodology, and regulatory requirements. Act as a subject matter expert (SME).
Risk ManagementIdentify and mitigate risks to project delivery and quality, supporting escalation and risk mitigation actions.
Lock And Unblinding ProcessLead the database lock and unblinding process; draft randomization specifications and perform quality control reviews.
Statistical ExpertiseProvide expert input on statistical review of deliverables, data management, and review of ADaM guides. Perform senior biostatistical review and quality control of sample size calculations.
Requirements:- Masters or PhD in Biostatistics or related field with 10+ years relevant experience.
- Expertise in complex statistical methods for Phase 2-3 trials.
- Experience as a statistical lead for regulatory submissions.
- In-depth knowledge of GCP, ICH guidelines, SAS or R, and CDISC standards.
- Strong communication, collaboration, and problem-solving skills.
- Experience in rare diseases and immunology is preferred.
We value diversity and are committed to inclusion. Join us in our mission to improve health outcomes globally.
Associate Director, Biostatistics (FSP - Permanent Homebased) employer: Nanosep AB
Contact Detail:
Nanosep AB Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Biostatistics (FSP - Permanent Homebased)
✨Tip Number 1
Network with professionals in the biostatistics field, especially those who have experience in regulatory submissions. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends.
✨Tip Number 2
Familiarise yourself with the specific statistical methodologies used in Phase 2-3 trials. Being able to discuss these methods confidently during interviews will demonstrate your expertise and readiness for the role.
✨Tip Number 3
Prepare to showcase your leadership skills by discussing past projects where you led teams or initiatives. Highlight your ability to collaborate across departments, as this is crucial for the Associate Director position.
✨Tip Number 4
Stay updated on GCP, ICH guidelines, and CDISC standards. Being well-versed in these regulations will not only help you in the application process but also show your commitment to maintaining high standards in biostatistics.
We think you need these skills to ace Associate Director, Biostatistics (FSP - Permanent Homebased)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in biostatistics, particularly your expertise in complex statistical methods for Phase 2-3 trials. Emphasise any leadership roles you've held and your experience with regulatory submissions.
Craft a Compelling Cover Letter: Write a cover letter that clearly outlines your motivation for applying to Nanosep AB. Discuss how your background aligns with the responsibilities of the Associate Director role, particularly your experience in liaising with cross-functional teams and your knowledge of GCP and ICH guidelines.
Showcase Your Communication Skills: In your application, provide examples of how you've effectively communicated complex statistical concepts to non-statistical audiences. This is crucial for the role, as you'll be representing sponsors at regulatory meetings.
Highlight Relevant Projects: Include specific projects where you led major initiatives or contributed significantly to clinical development plans. Detail your role in these projects, especially in terms of risk management and quality control processes.
How to prepare for a job interview at Nanosep AB
✨Showcase Your Statistical Expertise
Be prepared to discuss your experience with complex statistical methods, particularly in Phase 2-3 trials. Highlight specific projects where you led statistical analysis and how your contributions impacted the outcomes.
✨Demonstrate Leadership Skills
Since the role involves leading major projects, be ready to share examples of how you've successfully managed teams or projects in the past. Discuss your approach to mentoring others and ensuring quality in statistical planning and reporting.
✨Familiarise Yourself with Regulatory Standards
Understand GCP, ICH guidelines, and CDISC standards thoroughly. Be prepared to answer questions on how you have applied these regulations in previous roles, especially in relation to regulatory submissions.
✨Engage in Knowledge Sharing
Express your commitment to staying updated on developments in biostatistics and clinical trial methodology. Share any experiences you have in teaching, presenting, or preparing manuscripts, as this shows your dedication to knowledge sharing within the field.
