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- Tasks: Lead and support clinical trials using advanced statistical methods.
- Company: Cytel, a leader in clinical development with a focus on innovation.
- Benefits: Remote work, competitive salary, and continuous training opportunities.
- Why this job: Make a real impact in patient treatment while collaborating with top pharmaceutical clients.
- Qualifications: Master’s degree in statistics and 5+ years in clinical trials required.
- Other info: Join a dynamic team with excellent career growth potential.
The predicted salary is between 36000 - 60000 £ per year.
An experienced Biostatistician with a passion for clinical development and analysis, adept at utilizing advanced statistical methods, you will support or lead one or more Phase I-IV clinical studies. You are excited and enthusiastic. You 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. You motivate others to do the same.
As a Senior 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.
Position Overview: Our Senior Biostatisticians lead and support clinical trials in different phases of development. They may also support activities at indication or compound level, perform ad-hoc or exploratory analyses, support submission activities or Health Authority Questions. Having exposure to regulatory work experience is a bonus, for example, if you understand the regulatory questions and translating them to statistical problems, collaborating effectively, with clinical and regulatory colleagues. Supporting medium complexity clinical trials (starting from Design to Archival experience) and supporting some project-level activities.
Responsibilities
- Providing statistical support to clinical studies
- 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 and interpreting statistical results
- Preparing clinical study reports and potentially integrated summaries for submissions
- Utilizing your strong communication skills to present and explain the methodology and consequences of decisions
- Understanding and following ICH and Health Authority regulations which affect the reporting of clinical trial data. This includes good clinical practice and guidelines for electronic submissions
- Driving and supporting publication related activities and ad-hoc requests
- Contributing to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
- Participating in the review of CRFs, edit check specifications, and data validation plans
- Providing review and/or author data transfer specifications for external vendor data
- Collaborating with internal and external functions (e.g. CROs, software vendors, clinical development partners, etc.) to ensure meeting project timelines and goals
- Providing review and/or author SOPs and/or Work Instructions related to statistical programming practices
Qualifications
Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:
- Master’s degree in statistics or a related discipline. Ph.D. is a plus.
- 5+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry.
- Experience working for a CRO is strongly desired.
- Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports.
- Experience with Integrated Summaries for submission, safety reporting, regulatory questions etc. is a plus.
- Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers.
- Knowledge of R programming is highly desirable.
- Solid understanding & implementation of CDISC requirements for regulatory submissions.
- Adept in ADaM specifications generation and QC of datasets.
- The ability to build strong external & internal relationships and motivate a regional or global team.
- Effective communication skills: able to explain methodology and consequences of decisions in lay terms.
Senior Biostatistician FSP employer: Cytel Inc
Contact Detail:
Cytel Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Biostatistician FSP
✨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. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to biostatistics and clinical trials. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your experience effectively.
✨Tip Number 3
Show your enthusiasm! When you get the chance to speak with potential employers, let your passion for clinical development shine through. Share your ideas on how you can contribute to their projects and drive innovation forward.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got a range of exciting opportunities waiting for you. Plus, it’s a great way to ensure your application gets the attention it deserves from our hiring team.
We think you need these skills to ace Senior Biostatistician FSP
Some tips for your application 🫡
Show Your Passion: When writing your application, let your enthusiasm for clinical development shine through. We want to see how excited you are about the role and how you can motivate others to push boundaries in biostatistics.
Tailor Your CV: Make sure your CV highlights relevant experience in clinical trials and statistical methods. We love seeing specific examples of your work that align with the responsibilities listed in the job description.
Be Clear and Concise: In your cover letter, get straight to the point. We appreciate clear communication, so explain your qualifications and how they relate to the role without unnecessary fluff.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensure you’re considered for this exciting opportunity.
How to prepare for a job interview at Cytel Inc
✨Know Your Stats
Brush up on your advanced statistical methods and be ready to discuss how you've applied them in clinical studies. Be prepared to explain sample size calculations and the development of statistical analysis plans (SAPs) in a way that shows your deep understanding.
✨Show Your Passion
Let your enthusiasm for clinical development shine through. Share specific examples of how you've motivated teams or pushed projects forward. This role is all about innovation, so demonstrate your excitement for contributing to the next generation of patient treatment.
✨Communicate Clearly
Practice explaining complex statistical concepts in layman's terms. The ability to communicate effectively with both technical and non-technical stakeholders is crucial. Think of examples where you successfully bridged the gap between data and decision-making.
✨Familiarise with Regulations
Make sure you're well-versed in ICH guidelines and Health Authority regulations. Be ready to discuss how these impact clinical trial reporting and your experience with regulatory submissions. Showing that you understand the bigger picture will set you apart.
