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- Tasks: Lead and support clinical studies using advanced statistical methods in Rare Disease.
- Company: Join a leading pharmaceutical company focused on innovative therapies.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a real difference in patients' lives through impactful clinical research.
- Qualifications: Master’s degree in statistics; PhD preferred with 8+ years in clinical trials.
- Other info: Collaborative team environment with a focus on flexibility and adaptability.
The predicted salary is between 60000 - 84000 £ per year.
As Principal Biostatistician, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-III clinical studies, with a focus on multiple therapeutic areas, particularly Rare Disease.
RESPONSIBILITIES
- Providing statistical support to clinical studies, with a focus on Rare Disease;
- Participating in the development of study protocols, including participation in study design discussions and sample size calculations;
- Reviewing CRFs and data review guidelines; developing statistical analysis plans (SAPs), including analysis dataset and TLG specifications;
- Performing statistical analyses;
- Interpreting statistical results;
- Preparing clinical study reports, including integrated summaries for submissions;
- Leading study activities when called upon;
- Utilizing your strong communication skills to present and explain methodology and consequences of decisions in lay terms;
- Serving as a team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
QUALIFICATIONS
- Master’s degree in statistics or a related discipline. PhD strongly desired.
- 8+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry. Experience working for a CRO strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP and preparing clinical study reports including integrated summaries for submissions.
- Knowledge and implementation of advanced statistical methods, like longitudinal data analyses, missing data imputations, Survival analyses, etc.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables and working closely with Programmers. Knowledge of R programming a plus.
- Strong knowledge of ICH guidelines.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- Submissions experience is preferred.
- Experience working with cross-functional teams and representing the statistics group.
- Effective communicator: able to explain methodology and consequences of decisions in lay terms.
- Team player; willingness to go the extra distance to get results, meet deadlines, etc.
- Ability to be flexible when priorities change and deal with ambiguity.
Principal Biostatistician FSP - Hybrid Model in London employer: Cytel - EMEA
Contact Detail:
Cytel - EMEA Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Biostatistician FSP - Hybrid Model in 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 clinical trials. 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 study support. Be ready to discuss specific projects where you've made an impact!
✨Tailor Your Approach
Every interaction counts! Whether it’s a casual coffee chat or a formal interview, tailor your conversation to reflect the needs of the role. Show them how your background in rare diseases and clinical trials makes you the perfect fit.
✨Apply Through Us!
Don’t forget to check out our website for job openings! Applying through StudySmarter not only gives you access to exclusive roles but also connects you with a community that understands your skills and aspirations.
We think you need these skills to ace Principal Biostatistician FSP - Hybrid Model in London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in clinical trials and advanced statistical methods. We want to see how your background aligns with the role of Principal Biostatistician, especially in Rare Disease.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about biostatistics and how your skills can contribute to our team. Don’t forget to mention your experience with sample size calculations and SAPs!
Showcase Your Communication Skills: Since effective communication is key for this role, make sure to demonstrate your ability to explain complex statistical concepts in simple terms. We love seeing candidates who can bridge the gap between stats and real-world applications.
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!
How to prepare for a job interview at Cytel - EMEA
✨Know Your Stats
Brush up on advanced statistical methods relevant to the role, like longitudinal data analyses and survival analyses. Be ready to discuss how you've applied these techniques in past projects, especially in clinical trials.
✨Protocol Proficiency
Familiarise yourself with the development of study protocols and statistical analysis plans (SAPs). Prepare to explain your experience with sample size calculations and how you’ve contributed to protocol concept development.
✨Communication is Key
Practice explaining complex statistical concepts in simple terms. You’ll need to demonstrate your ability to communicate effectively with cross-functional teams, so think of examples where you’ve successfully done this.
✨Team Player Mindset
Showcase your collaborative spirit! Be prepared to share instances where you went the extra mile to meet deadlines or support your team. Highlight your flexibility in adapting to changing priorities, as this is crucial in a dynamic environment.
