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- Tasks: Lead Phase III/IV clinical studies and provide statistical expertise for innovative medical projects.
- Company: Join a global pharmaceutical client dedicated to transforming patient treatment.
- Benefits: Competitive salary, flexible work environment, and opportunities for professional growth.
- Why this job: Make a real impact in clinical development while working with cutting-edge statistical methods.
- Qualifications: Master’s or PhD in statistics, clinical trial experience, and strong programming skills.
- Other info: Collaborative culture with excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 £ per year.
An experienced Principal Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will lead Phase III/IV clinical studies across your region including their medical affairs activities. You are excited and enthusiastic, motivate your teams to do great work and collaborate easily with your clients. You never settle for what is, but always push clinical development forward to what it could be.
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you will be at the heart of our client’s innovation. As a Biostatistician you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
Our Principal Biostatisticians provide statistical and development support and influence for the associated client’s trials providing expertise into processes, clinical development plans, concept sheets and protocols, as well as potentially providing oversight of work supported by other vendors. You will formulate integrated analytical approaches to mine data sources, employ statistical methods, machine learning & deep learning algorithms to discover actionable insights and automate processes for reducing effort and time for repeated use.
RESPONSIBILITIES- Provide statistical input into study protocols, Case Report Forms, and data management plans, DMCs and write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- Provide guidance and support data analysis such as longitudinal and time-to-event.
- Provide statistical output as required for manuscripts and presentations and ensure that the results are accurately interpreted in the publications.
- Review and contribute to study reports and clinical and statistical sections of regulatory submission dossiers, lead electronic submissions of clinical data to regulatory authorities, and participate in meetings with regulatory authorities.
- When in the Lead Biostatistician role for a project: manage biostatisticians and statistical programmers with respect to statistical strategy, deliverables and processes.
- Generate the use of innovative statistical methodology approaches by identifying, adapting, developing or using optimal statistical research methodologies and techniques appropriate to each project, and contribute internally and externally to the development and visibility of the company and of the Clinical Services department through expertise and customer orientation.
- Contribute to the development of sourcing strategy for projects.
- Develop strong collaboration and communication with sponsor cross-functional teams and sponsor Biostatistics management.
- Master’s degree or PhD in statistics or a related discipline required, along with clinical trial experience.
- Ability to work independently, demonstrate initiative and flexibility through effective and innovative leadership.
- Attention to detail and quality focused, excellent interpersonal and communication skills, innovative, and collaborative behaviours.
- Late phase and medical affairs experience required.
- Working CDISC knowledge required.
- SAS or R programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
- Ability to organize multiple work assignments and establish priorities.
Principal Biostatistician FSP - Medical Affairs in City of London employer: Cytel - EMEA
Contact Detail:
Cytel - EMEA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Biostatistician FSP - Medical Affairs in City of London
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to biostatistics and medical affairs. You never know who might have a lead on your dream job!
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience with advanced statistical methods and clinical trials. Share specific examples of how you've contributed to successful projects – this will set you apart from the crowd!
✨Tailor Your Approach
Every company is different, so do your homework! Understand the specific needs of the pharmaceutical client you're applying to and tailor your conversations to show how your skills can help them achieve their goals.
✨Apply Through Our Website
Don't forget to check out our website for job openings! Applying directly through us not only shows your interest but also gives you a better chance of landing that Principal Biostatistician role. Let's get you started on this exciting journey!
We think you need these skills to ace Principal Biostatistician FSP - Medical Affairs in City of London
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for clinical development shine through. We want to see that you're not just qualified, but genuinely excited about the role and how you can contribute to pushing clinical development forward.
Tailor Your CV: Make sure your CV is tailored to highlight your experience in biostatistics and clinical trials. We love seeing specific examples of your work, especially those that align with the responsibilities mentioned in the job description.
Be Clear and Concise: Keep your application clear and to the point. We appreciate well-structured applications that make it easy for us to see your qualifications and experiences without wading through unnecessary fluff.
Apply Through Our Website: Don’t forget to apply 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 serious about joining our team at StudySmarter.
How to prepare for a job interview at Cytel - EMEA
✨Know Your Stats
Brush up on your statistical methods and clinical trial experience. Be ready to discuss specific methodologies you've used in past projects, especially those relevant to Phase III/IV studies. This shows you’re not just familiar with the theory but can apply it practically.
✨Show Your Leadership Skills
Prepare examples of how you've motivated teams or led projects in the past. Highlight your ability to collaborate with cross-functional teams and how you’ve driven innovation in your previous roles. This will demonstrate that you can take ownership and lead effectively.
✨Be Ready for Technical Questions
Expect questions about SAS or R programming, as well as CDISC standards. Brush up on your coding skills and be prepared to discuss how you’ve used these tools to QC outputs or generate statistical analyses. Practical knowledge here is key!
✨Communicate Clearly
Practice explaining complex statistical concepts in simple terms. You might need to present your findings or methodologies to non-statistical stakeholders, so being able to communicate clearly and effectively is crucial. Think about how you can make your insights accessible to everyone.
