At a Glance
- Tasks: Lead statistical activities for pre-clinical studies and collaborate with cross-functional teams.
- Company: Join Cytel, a leader in biostatistics with a commitment to innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact in drug development while working with cutting-edge statistical methodologies.
- Qualifications: Ph.D. or MS in Statistics/Biostatistics with 6+ years of industry experience.
- Other info: Dynamic work environment with strong mentorship and career advancement opportunities.
The predicted salary is between 54000 - 84000 ÂŁ per year.
As a Principal Biostatistician, you are responsible for statistical activities in support of preâclinical trials, including assay qualification, doseâresponse analysis, and data visualization.
Responsibilities
- Provide statistical leadership and expertise into preâclinical studies, representing Cytel and the statistical team on the Development Teams of sponsors.
- Lead statistical activities on assigned projects, ensuring alignment of objectives and delivery of statistical output on time and meeting project requirements, coordinating all statistical aspects across multiple projects.
- Provide statistical input into study concept, Case Report Forms, and data management plans, write statistical analysis plans, review or create analysis dataset specifications, and perform statistical analyses.
- 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 crossâfunctional teams and sponsor Biostatistics management.
Qualifications
- Minimum Education: Ph.D. or MS in Statistics, Biostatistics or related discipline.
- At least 6 years of experience as biostatistician in the Pharmaceutical/Biotechnology industry in clinical development/nonâclinical studies.
- At least 3 years of experience as a Lead Biostatistician for clinical/nonâclinical projects.
- Knowledge of relevant international regulatory guidelines applicable to clinical development, and some experience of regulatory interactions and data submission to FDA.
- Fluent in English.
- Working SAS and CDISC knowledge.
Skills
- Works effectively in international teams, operates within a matrix organization and with multiâdisciplinary groups.
- Understands and anticipates customer needs and responds to their inquiries.
- R coding, mixed models, flexible in approach, scientific curiosity, excellent at data visualization.
- Able to work on multiple projects.
- Experienced with assay qualification and doseâresponse analysis.
- Verbal and written communication is effective with multiâdisciplinary groups.
- Work is wellâorganized, of high quality, meeting timelines. Able to balance concurrent tasks and responsibilities.
- Excellent time management.
- Brings creative ideas and makes suggestions for optimization.
- Exhibits leadership for the biostatistics team working on the same clinical development teams.
- Exhibits the ability to mentor and develop statistical colleagues.
Principal Biostatistician FSP - Pre-clinical studies in London employer: Cytel
Contact Detail:
Cytel Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Principal Biostatistician FSP - Pre-clinical studies in London
â¨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups. We canât stress enough how important it is to build relationships; you never know who might help you land that Principal Biostatistician role.
â¨Show Off Your Skills
When you get the chance to chat with potential employers, donât hold back! Share your experiences with statistical methodologies and your leadership in biostatistics. We want to see your passion and expertise shine through!
â¨Tailor Your Approach
Every job is different, so make sure you tailor your conversations to the specific role. Highlight your experience with pre-clinical studies and regulatory submissions. Weâre all about making those connections count!
â¨Apply Through Our Website
Donât forget to apply directly through our website! Itâs the best way to ensure your application gets noticed. Weâre excited to see what you bring to the table as a Principal Biostatistician!
We think you need these skills to ace Principal Biostatistician FSP - Pre-clinical studies in London
Some tips for your application đŤĄ
Tailor Your CV: Make sure your CV is tailored to the Principal Biostatistician role. Highlight your experience in pre-clinical studies and any relevant statistical methodologies you've used. We want to see how your background aligns with our needs!
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. Be sure to mention any leadership experience you have, as we value that highly.
Showcase Your Technical Skills: Donât forget to highlight your technical skills, especially in SAS and R coding. Mention any innovative statistical methods you've employed in past projects. We love seeing creativity in problem-solving!
Apply Through Our Website: We encourage you to apply through our website for the best chance of getting noticed. Itâs the easiest way for us to keep track of your application and ensure it reaches the right people. Good luck!
How to prepare for a job interview at Cytel
â¨Know Your Stats
Brush up on your statistical methodologies and be ready to discuss how you've applied them in pre-clinical studies. Be prepared to explain your experience with assay qualification and dose-response analysis, as these are key areas for the role.
â¨Showcase Your Leadership Skills
As a Principal Biostatistician, you'll need to lead teams effectively. Think of examples where you've managed biostatisticians or statistical programmers, and be ready to share how you ensured project objectives were met while fostering collaboration.
â¨Understand Regulatory Guidelines
Familiarise yourself with international regulatory guidelines relevant to clinical development. Be prepared to discuss your experience with regulatory submissions and interactions, especially with the FDA, as this will demonstrate your readiness for the role.
â¨Communicate Clearly
Effective communication is crucial in this position. Practice articulating complex statistical concepts in simple terms, and think about how you've successfully collaborated with cross-functional teams in the past. This will show your ability to work well within a matrix organisation.