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- Tasks: Lead advanced statistical methodologies in clinical programmes and innovative trial designs.
- Company: Join a leading biotech firm focused on groundbreaking medical advancements.
- Benefits: Attractive salary, comprehensive health benefits, and opportunities for professional growth.
- Why this job: Make a significant impact in healthcare by shaping clinical trials and regulatory strategies.
- Qualifications: MSc or PhD in Statistics/Biostatistics with 8+ years of relevant experience.
- Other info: Collaborative environment with a focus on innovation and excellence.
The predicted salary is between 60000 - 84000 £ per year.
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 employer: Discover International
Contact Detail:
Discover International Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Biostatistics
✨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 knowledge of advanced statistical methodologies. Be ready to discuss your experience with adaptive designs and Bayesian approaches, as well as how you've contributed to regulatory submissions in the past.
✨Tip Number 3
Showcase your communication skills! Practice explaining complex statistical concepts in simple terms. This will not only help you in interviews but also demonstrate your ability to work with non-statisticians, which is key for this role.
✨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 standing out. Plus, it’s super easy to navigate!
We think you need these skills to ace Senior Manager, Biostatistics
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in biostatistics and clinical trial methodology. We want to see how your skills align with the job description, so don’t be shy about showcasing your expertise in advanced statistical techniques and regulatory submissions.
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 role. Mention specific projects or experiences that relate to the innovative trial designs and statistical methodologies we’re looking for.
Showcase Your Communication Skills: Since you'll need to explain complex methodologies to non-statisticians, make sure your application reflects your ability to communicate clearly. Use straightforward language and examples that demonstrate your knack for making statistics accessible.
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 you’re keen on joining our team at StudySmarter!
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 past projects, as this will show your expertise and relevance to the role.
✨Prepare for Regulatory Discussions
Since the role involves contributing to regulatory interactions, it’s crucial to familiarise yourself with the ICH E9 R1 estimands framework and recent guidance from health authorities like the EMA and FDA. Think of examples where you've successfully navigated these discussions and be prepared to share them.
✨Showcase Your Communication Skills
You’ll need to explain complex statistical concepts to non-statisticians, so practice simplifying your explanations. Consider preparing a few key points or analogies that can help convey your ideas clearly and effectively during the interview.
✨Demonstrate Leadership Experience
As a Senior Manager, you'll be expected to lead teams and oversee CROs. Prepare to discuss your management style and any relevant experiences where you’ve led projects or teams, ensuring you highlight your ability to deliver high-quality results under pressure.