At a Glance
- Tasks: Lead statistical strategies for clinical trials and regulatory submissions in a dynamic environment.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy competitive salary, health benefits, and a culture of inclusion and belonging.
- Other info: Collaborate with cross-functional teams and engage with major regulatory authorities.
- Why this job: Make a real impact on innovative therapies that help patients lead full lives.
- Qualifications: PhD or MS with extensive experience in drug development and statistical leadership.
The predicted salary is between 70000 - 90000 £ per year.
The Associate Director (AD), Biostatistics, leads the full scope of statistical contribution to a clinical development program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the program.
Main Responsibilities:
- Lead full scope of Biostatistics conduct for the responsible program within a therapeutic area.
- Define statistical strategy and ensure appropriate statistical methodologies applied to study design and data analysis for clinical trials and regulatory submissions.
- Influence and contribute to clinical development plans, collaborate with cross-functional team for governance reviews.
- Lead statistical strategy for planning and study execution (member of Study Executive Team, Clinical Development Team) and quantitative evaluation to clinical trials, regulatory submissions, and related documents.
- Provide statistical thought partnership for innovative study design and clinical development plans, including Go-No Go criteria and probability of technical success calculations.
- Provide for project-wide planning of analyses; quality and timely delivery of interim and final results, including integrated analyses for submissions.
- Represent Biostatistics in interactions with regulatory authorities (eg, FDA, EMA, PMDA).
- Be responsible for interpreting analysis results and ensuring reporting accuracy in study reports and regulatory documents.
- Manage outsourcing operations or work with internal statistical programmers within the responsible program. Ensure timeliness and quality of deliverables by CRO/FSP.
- Support or lead improvement initiatives within the department, organization and/or pharma industry.
- Prepare abstracts, posters, oral presentations and written reports to effectively communicate results of clinical programs and studies to internal and external stakeholders and colleagues with varying levels of clinical research knowledge.
Education and Experience:
- PhD with 8 years of experience or MS with 11 years of experience in drug development.
- Experience providing statistical leadership at compound/indication level.
- Demonstrated statistical expertise and leadership in facilitating and optimizing the (pre/early/full-) clinical development strategy.
- Solid experience in applications of advanced statistical methodologies.
- Leading roles in regulatory submissions.
- Experience in interactions with major regulatory authorities preferred.
- Experience with CROs (either managing a CRO, or having worked in a CRO) or managing internal deliveries preferred.
- Track record of innovation preferred.
Competencies:
- Familiarity with regulatory guidance and interactions.
- Broad knowledge of clinical development and processes.
- Ability to collaboratively work and provide leadership in matrix environment.
- Strong interpersonal and communication skills (verbal and written in English).
- Good working knowledge of SAS and/or R.
- Expertise in a range of statistical methodologies.
- Demonstrated use of innovative / creative methodology for analysis of clinical data.
- Familiarity with relevant regulatory guidance documents.
- Expertise in: CDISC, statistical programming, and/or data standards.
- Biostatistics and Statistical Programming Operations.
Associate Director, Biostatistics (2) in Maidenhead employer: CSL Behring
CSL Behring is an exceptional employer that prioritises innovation and employee growth within a collaborative and inclusive work culture. With a commitment to saving lives through cutting-edge biotherapeutics, employees benefit from comprehensive support for well-being, opportunities for professional development, and the chance to make a meaningful impact in the healthcare sector. Located in a dynamic environment, CSL Behring fosters a diverse workforce that thrives on curiosity and empathy, ensuring that every team member feels valued and empowered.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director, Biostatistics (2) in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field and let them know you're on the lookout for opportunities. You never know who might have the inside scoop on a role that’s perfect for you.
✨Tip Number 2
Prepare for interviews by brushing up on your statistical methodologies and regulatory knowledge. Be ready to discuss how you've applied these in past projects, especially in clinical trials and submissions.
✨Tip Number 3
Showcase your leadership skills! When chatting with potential employers, highlight your experience in leading cross-functional teams and your ability to influence clinical development plans.
✨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 Associate Director, Biostatistics (2) in Maidenhead
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Associate Director, Biostatistics role. Highlight your relevant experience in statistical strategies and clinical trials, as this will show us you understand what we're looking for.
Showcase Your Expertise:Don’t hold back on showcasing your statistical expertise! Include specific examples of how you've led statistical strategies or contributed to regulatory submissions. We want to see your thought leadership in action!
Be Clear and Concise:When writing your application, keep it clear and to the point. Use straightforward language to explain your experience and achievements. We appreciate clarity, especially when it comes to complex topics like biostatistics.
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 to do!
How to prepare for a job interview at CSL Behring
✨Know Your Statistical Strategies
Make sure you brush up on the statistical methodologies relevant to clinical trials. Be prepared to discuss how you've applied these strategies in past projects, especially in regulatory submissions. This will show your depth of knowledge and experience.
✨Showcase Your Leadership Skills
As an Associate Director, you'll need to demonstrate your ability to lead cross-functional teams. Think of examples where you've influenced clinical development plans or collaborated with others to achieve a common goal. Highlighting these experiences will set you apart.
✨Familiarise Yourself with Regulatory Interactions
Since you'll be representing Biostatistics in discussions with regulatory authorities, it's crucial to understand their expectations. Research recent interactions and submissions related to your therapeutic areas to discuss during the interview.
✨Prepare for Innovative Thinking
Be ready to talk about innovative study designs and methodologies you've used in the past. Think about how you can contribute to improvement initiatives within the department and the industry. This shows you're not just a follower but a leader in biostatistics.
