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- Tasks: Lead and support clinical studies using advanced statistical methods in Rare Disease.
- Company: Dynamic biotech 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 research.
- Qualifications: Master’s degree in statistics; PhD preferred with 8+ years in clinical trials.
- Other info: Collaborative team environment with a focus on innovation and flexibility.
The predicted salary is between 48000 - 72000 £ 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 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
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals 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 Principal Biostatistician role.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methods and clinical trial knowledge. We recommend practising common interview questions and even doing mock interviews with friends or colleagues. This way, you’ll be ready to showcase your expertise and communication skills when discussing methodologies.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, send a thank-you email to express your appreciation for the opportunity. It shows your enthusiasm for the role and keeps you fresh in their minds. We believe this small gesture can make a big difference!
✨Tip Number 4
Apply directly through our website! We often have exclusive listings and updates that you won’t find elsewhere. Plus, it gives us a chance to see your application first-hand, which can really help you stand out in the crowd.
We think you need these skills to ace Principal Biostatistician FSP - Hybrid Model
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 Inside Out
Make sure you 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.
✨Master the Protocols
Familiarise yourself with the development of study protocols and statistical analysis plans (SAPs). Prepare examples of your experience in sample size calculations and protocol concept development to showcase your expertise.
✨Communicate Like a Pro
Since strong communication skills are key, practice explaining complex statistical concepts in simple terms. Think of scenarios where you had to present findings to non-statistical team members and how you made it understandable.
✨Be a Team Player
Highlight your collaborative experiences, especially in cross-functional teams. Share instances where you went the extra mile to meet deadlines or support colleagues, as this shows your commitment to teamwork and results.
