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For Companies At a Glance
- Tasks: Lead clinical studies and apply advanced statistical methods to drive drug development.
- Company: Join a leading pharmaceutical company with a focus on innovation and collaboration.
- Benefits: Enjoy a competitive salary, hybrid work model, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare by contributing to groundbreaking clinical trials.
- Qualifications: Ph.D. in Biostatistics or equivalent experience; strong communication and programming skills required.
- Other info: Dynamic team environment with excellent career advancement opportunities.
The predicted salary is between 36000 - 60000 £ per year.
The role involves leading Phase I–IV clinical studies across the region, applying advanced statistical methods, and collaborating with clients and internal teams to drive clinical development forward.
Responsibilities
- Represents biostatistics at cross-functional team meetings to drive clinical development of drug candidates and provides input on clinical development plans.
- Collaborates with Clinical Development, Regulatory and Clinical Operations Expertise Areas to design clinical trials.
- Writes the statistical sections of clinical trial protocols, consulting with internal and external experts.
- Contributes to or prepares statistical analysis plans.
- Collaborates with Data Management, Clinical Development and Clinical Operations on the design of eCRFs.
- Provides statistical guidance on the conduct of ongoing trials.
- Collaborates with Statistical Programmers on summary and analysis of trial data.
- Writes ADS and ad hoc analysis specifications.
- Contributes to clinical study reports and other regulatory documents (e.g., DSURs, Briefing Documents).
- Represents the sponsor in meetings with regulators, Key Opinion Leaders, partners, and other stakeholders.
- Contributes to scientific articles, summarizing data collected in trials.
- Participates in other activities and meetings to support Biostatistics and the Development Team as needed.
- Consults with Research & Preclinical colleagues on statistical questions in their work.
- Manages CRO statistical and programming support.
Qualifications
- Ph.D. in Biostatistics or Statistics or equivalent with proven pharmaceutical biostatistics experience; or an MS with at least 10 years of relevant experience.
- Excellent written and oral communication and presentation skills.
- Experience programming in SAS.
- Interest in and basic understanding of biology and biological processes, including RNAi.
- Experience in clinical development through Phase 3 (NDA submission).
- Experience as lead statistician for a compound.
- Understanding of ICH GCP and general industry practices and standards.
- Proficiency in R and other statistical software, including EAST.
- Experience with CDISC (SDTM, ADaM, CDASH).
- Experience representing sponsors in meetings with US FDA and international regulatory authorities.
- Experience designing and conducting adaptive trials.
Employment details
- Location: London, England, United Kingdom (Hybrid).
- Job function: Science.
- Seniority level: Mid-Senior level.
- Employment type: Full-time.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.
Associate Director, Biostatistics FSP Hybrid (At least 2 Days Onsite) in City of London employer: TREIZE-QUARANTE (1340)
Contact Detail:
TREIZE-QUARANTE (1340) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, Biostatistics FSP Hybrid (At least 2 Days Onsite) in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field and let them know you're on the hunt for opportunities. You never know who might have a lead or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methods and clinical trial knowledge. Be ready to discuss your experience with SAS and R, as well as any adaptive trials you've worked on. Confidence is key!
✨Tip Number 3
Showcase your communication skills! During interviews, make sure to highlight your ability to collaborate with cross-functional teams and represent sponsors in meetings. This will set you apart from other candidates.
✨Tip Number 4
Don't forget to apply through our website! We love seeing applications directly from motivated candidates like you. Plus, it gives us a chance to see your enthusiasm for the role right from the start.
We think you need these skills to ace Associate Director, Biostatistics FSP Hybrid (At least 2 Days Onsite) in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences mentioned in the job description. Highlight your biostatistics expertise and any relevant clinical trial experience to catch our eye!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're the perfect fit for the Associate Director role. Share your passion for biostatistics and how you can contribute to our team at StudySmarter.
Showcase Your Communication Skills: Since excellent communication is key for this role, make sure your application showcases your ability to convey complex statistical concepts clearly. We want to see how you can represent us in meetings with stakeholders!
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’s super easy!
How to prepare for a job interview at TREIZE-QUARANTE (1340)
✨Know Your Stats
Brush up on your biostatistics knowledge, especially around advanced statistical methods relevant to clinical trials. Be ready to discuss how you've applied these methods in past projects, as this will show your expertise and confidence.
✨Collaborate Like a Pro
Since the role involves a lot of collaboration, think of examples where you've successfully worked with cross-functional teams. Prepare to share how you’ve contributed to clinical development plans and how you handle differing opinions in a team setting.
✨Master the Protocols
Familiarise yourself with writing statistical sections of clinical trial protocols. Be prepared to discuss your experience with regulatory documents and how you ensure compliance with ICH GCP standards. This will demonstrate your thorough understanding of the process.
✨Showcase Your Communication Skills
As excellent communication is key for this role, practice articulating complex statistical concepts in simple terms. Think about how you would explain your work to non-statisticians, as this will highlight your ability to engage with various stakeholders effectively.