At a Glance
- 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 clinical development and engage with regulatory authorities.
- Qualifications: MSc or PhD in Statistics/Biostatistics with 8+ years of relevant experience.
- Other info: Collaborative environment with a focus on innovation and career advancement.
The predicted salary is between 72000 - 108000 £ 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 City of 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 City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field and let them know you're on the hunt for a Senior Manager role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methodologies and clinical trial designs. Be ready to discuss your experience with adaptive designs and Bayesian approaches, as these are hot topics in the industry right now.
✨Tip Number 3
Showcase your expertise in regulatory interactions! Make sure you can talk confidently about your past experiences with health authorities like the MHRA and FDA. This will set you apart from other candidates.
✨Tip Number 4
Don't forget to apply through our website! We’ve got some fantastic opportunities waiting for you, and applying directly can give you a better chance of landing that dream job in biostatistics.
We think you need these skills to ace Senior Manager, Biostatistics in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your expertise in advanced statistical methodologies and any relevant clinical trial experience to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Senior Manager, Biostatistics role. Share examples of your past work with innovative trial designs and regulatory submissions to show us what you can bring to the table.
Showcase Your Communication Skills: Since you'll need to explain complex methodologies to non-statisticians, make sure your application demonstrates your ability to communicate clearly. Use straightforward language and avoid jargon where possible to show us you can bridge that gap!
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’re considered for the role. Plus, it shows us you’re keen on joining the StudySmarter team!
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 regulatory interactions are a key part of the role, think about your past experiences with health authorities. Prepare examples of how you've contributed to regulatory submissions or meetings, and be ready to explain complex statistical concepts in simple terms.
✨Showcase Your Leadership Skills
As a Senior Manager, you'll need to demonstrate your ability to lead teams and projects. Think of specific instances where you've successfully managed CROs or led statistical strategy development. Highlight your communication skills and how you've ensured high-quality deliverables.
✨Stay Current with Industry Trends
Familiarise yourself with the latest statistical guidance and industry best practices. Being able to discuss recent developments or changes in biostatistics will show that you're proactive and engaged in your field, which is a big plus for any employer.