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- Tasks: Lead innovative statistical strategies for clinical trials and ensure high-quality deliverables.
- Company: Join a leading biotech firm dedicated to advancing healthcare through data-driven insights.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for professional growth.
- Why this job: Make a real impact in biostatistics and contribute to groundbreaking clinical developments.
- Qualifications: MSc or PhD in Statistics/Biostatistics with 8+ years of relevant experience.
- Other info: Collaborative environment with a focus on innovation and regulatory excellence.
The predicted salary is between 60000 - 84000 £ per year.
Key Responsibilities:
- Statistical Strategy & Methodology
- Lead the development and implementation of advanced statistical methodologies across clinical programs.
- Contribute to innovative trial designs including adaptive designs, Bayesian approaches, seamless Phase II/III designs, enrichment strategies, and interim analyses.
- Provide expertise in estimands framework (ICH E9 R1) and support alignment of objectives, endpoints, and analysis strategies.
- Advise on multiplicity control, missing data strategies, and sensitivity analyses.
- Clinical Development Support
- Lead statistical input into clinical development plans and protocol design.
- Author and review statistical sections of protocols, SAPs, and regulatory documents.
- Oversee statistical analyses and outputs from CROs.
- Ensure high-quality deliverables in compliance with ICH, GCP, and regulatory expectations.
- Regulatory & External Engagement
- Contribute to regulatory interactions (e.g., Scientific Advice, MHRA, EMA, FDA).
- Prepare briefing documents and represent Biostatistics in meetings with health authorities.
- Stay current with emerging statistical guidance and industry best practices.
Qualifications & Experience:
- MSc or PhD in Statistics, Biostatistics, or related quantitative discipline.
- Minimum 8+ years of experience in biostatistics within biotech or pharmaceutical development.
- Strong hands-on experience in clinical trial methodology and advanced statistical techniques.
- Demonstrated experience supporting regulatory submissions and authority interactions.
- Proficiency in SAS and/or R.
- Experience managing or overseeing CROs preferred.
- Excellent communication skills and ability to explain complex methodology to non-statisticians.
Senior Manager, Biostatistics in London employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Biostatistics in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field, attend industry events, and engage on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that Senior Manager role.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methodologies and clinical trial designs. We recommend practising common interview questions and even doing mock interviews with friends or colleagues. Show them you’re the expert they need!
✨Tip Number 3
Don’t forget to showcase your experience with regulatory submissions and authority interactions. We want to see how you’ve contributed to successful projects in the past. Bring those examples to the forefront during discussions!
✨Tip Number 4
Apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. Let’s get you that Senior Manager position together!
We think you need these skills to ace Senior Manager, Biostatistics in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in biostatistics and clinical trial methodology. We want to see how your skills align with the key responsibilities listed in the job description.
Craft a Compelling Cover Letter: Your cover letter should tell us why you're the perfect fit for the Senior Manager role. Share specific examples of your past work, especially around statistical methodologies and regulatory submissions, to really grab our attention.
Showcase Your Technical Skills: Don’t forget to mention your proficiency in SAS and/or R! We’re looking for someone with strong hands-on experience, so make sure to highlight any relevant projects or analyses you've worked on.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from us during the process.
How to prepare for a job interview at Discover International
✨Know Your Stats Inside Out
Make sure you brush up on advanced statistical methodologies, especially those mentioned in the job description like Bayesian approaches and adaptive designs. Be ready to discuss how you've applied these techniques in your previous roles, as this will show your expertise and confidence.
✨Prepare for Regulatory Discussions
Since the role involves regulatory interactions, it’s crucial to familiarise yourself with the latest guidelines from authorities like the EMA and FDA. Think of examples where you've contributed to regulatory submissions or interacted with health authorities, as this will demonstrate your experience and readiness for the role.
✨Showcase Your Communication Skills
You’ll need to explain complex statistical concepts to non-statisticians, so practice simplifying your explanations. Prepare a few scenarios where you successfully communicated intricate methodologies to diverse audiences, highlighting your ability to bridge the gap between statistics and practical application.
✨Demonstrate Leadership in Biostatistics
As a Senior Manager, you'll be expected to lead teams and oversee CROs. Think about your past experiences managing projects or teams, and be ready to share how you ensured high-quality deliverables while maintaining compliance with ICH and GCP standards. This will showcase your leadership capabilities and commitment to excellence.