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- Tasks: Lead and support clinical studies using advanced statistical methods in Rare Disease.
- Company: Dynamic biopharmaceutical company focused on innovative therapies.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team environment with a focus on innovation and flexibility.
- 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.
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 with a focus on 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 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 and meet deadlines.
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 and meet deadlines.
- Ability to be flexible when priorities change and deal with ambiguity.
Principal Biostatistician FSP - Hybrid Model in City of Westminster 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 City of Westminster
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field, especially those who work in clinical trials. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methods and real-world applications. Be ready to discuss how you've tackled challenges in past projects, especially in rare diseases. We want to see your problem-solving skills in action!
✨Tip Number 3
Showcase your communication skills! Practice explaining complex statistical concepts in simple terms. This will not only impress interviewers but also demonstrate your ability to work with cross-functional teams.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Principal Biostatistician FSP - Hybrid Model in City of Westminster
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 ICH guidelines and CDISC requirements!
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 data and decision-making.
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
As a Principal Biostatistician, you’ll need to showcase your expertise in advanced statistical methods. Brush up on key concepts like sample size calculations and survival analyses. Be ready to discuss how you've applied these methods in past clinical studies, especially in the context of Rare Diseases.
✨Prepare for Protocol Discussions
Since you'll be involved in developing study protocols, it’s crucial to understand the nuances of protocol concept development. Think about specific examples where you contributed to study design discussions and how you approached challenges in those scenarios.
✨Communicate Like a Pro
Strong communication skills are essential for this role. Practice explaining complex statistical concepts in simple terms. You might be asked to present your methodology during the interview, so prepare a few examples that demonstrate your ability to convey information clearly and effectively.
✨Show Your Team Spirit
Being a team player is key in this position. Reflect on times when you went the extra mile to support your colleagues or meet deadlines. Be ready to share these experiences, as they will highlight your collaborative nature and commitment to achieving results together.