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- Tasks: Lead statistical strategy for innovative gene therapy development and collaborate with cross-functional teams.
- Company: Join Orchard Therapeutics, a global leader in gene therapy based in London.
- Benefits: Enjoy a hybrid work model, competitive salary, and a commitment to diversity and inclusion.
- Why this job: Make a real impact on patients' lives through cutting-edge gene therapies.
- Qualifications: 8+ years in drug development, MSc/PhD in statistics, and strong communication skills.
- Other info: Dynamic environment with opportunities for career growth and innovation.
The predicted salary is between 48000 - 72000 ÂŁ per year.
Location: London/Hybrid
Reporting to: Head of Biostatistics
Orchard Therapeutics, a Kyowa Kirin company, is a global gene therapy leader focused on transforming the lives of patients with rare disorders through innovative gene therapies based on gene-modified hematopoietic stem cells (HSCs). Orchard has its global headquarters in London, England, and its U.S. headquarters in Boston, Massachusetts.
Job Summary
The Director, Biostatistics, is a handsâon leadership role within a crossâfunctional program team, providing an opportunity to contribute strategic statistical thinking to all aspects of clinical drug development in a dynamic environment. You will be responsible for the statistical strategy of a gene therapy development program, ensuring data and statistical quality, relevance to regulatory and payer requirements, and scientific validity.
Key Responsibilities
- Strategic input: Collaborate with clinical, regulatory and medical affairs colleagues to develop and implement a strategy for clinical development.
- Regulatory engagement: Contribute to regulatory briefing documents, act as the lead statistical consultant during regulatory meetings, address questions from regulatory authorities, and incorporate regulatory feedback into study documents.
- Study design: Provide technical input into program and study design, specifically sample size justification and the specification of estimands.
- Analysis and reporting: Lead the creation of statistical analysis plans/display shells, ensure accurate interpretation of analysis results in clinical study reports, regulatory submission documents, and market access dossiers; review and input into publications, including provision of ad hoc analyses as required.
- Operational oversight: Effectively manage vendors/CROs to ensure quality deliverables, adherence to timelines and efficient resource utilization, review case report forms and other study documents, review protocol deviations, contribute to risk management, and maintain the trial master file.
Requirements / Key Competencies
- 8+ years' experience working as a statistician in drug development including experience as a project lead statistician and significant interactions with regulatory authorities.
- MSc or PhD in statistics or related discipline.
- Successful experience in regulatory submissions, including MAAs, NDAs/BLAs, and other filings.
- Ability to independently undertake new and highly complex tasks requiring advanced analytical thought.
- Excellent communication skills and in particular the ability to communicate complex statistical concepts to non-statisticians.
- Demonstrated experience in implementing innovative statistical methodologies to enhance clinical trial efficiency and effectiveness (experience with rare diseases, small populations or Bayesian methodology would be an advantage).
- Handsâon experience with SAS (experience with R is an advantage); good knowledge of CDISC standards.
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications. We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.
Director, Biostatistics employer: Orchard Therapeutics - U.S.
Contact Detail:
Orchard Therapeutics - U.S. Recruiting Team
StudySmarter Expert Advice đ¤Ť
We think this is how you could land Director, Biostatistics
â¨Tip Number 1
Network like a pro! Reach out to your connections in the biostatistics field, especially those who work at Orchard or similar companies. A friendly chat can open doors and give you insider info on job openings.
â¨Tip Number 2
Prepare for interviews by brushing up on your statistical methodologies and regulatory knowledge. Be ready to discuss how you've tackled complex tasks in the past, as this will show you're the hands-on leader they need.
â¨Tip Number 3
Showcase your communication skills! Practice explaining complex statistical concepts in simple terms. This is crucial, especially when interacting with non-statisticians during interviews.
â¨Tip Number 4
Don't forget to apply through our website! Itâs the best way to ensure your application gets noticed. Plus, it shows you're genuinely interested in joining the Orchard team.
We think you need these skills to ace Director, Biostatistics
Some tips for your application đŤĄ
Tailor Your CV: Make sure your CV is tailored to the Director, Biostatistics role. Highlight your experience in drug development and any regulatory submissions you've been involved in. We want to see how your skills align 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 gene therapy and how your strategic statistical thinking can contribute to our mission. Keep it engaging and relevant to the role.
Showcase Your Communication Skills: Since you'll be communicating complex statistical concepts to non-statisticians, make sure to demonstrate your communication skills in your application. We love seeing examples of how you've made complex ideas accessible in the past!
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. Itâs straightforward and ensures your application goes directly to us. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at Orchard Therapeutics - U.S.
â¨Know Your Stats Inside Out
As a Director of Biostatistics, youâll need to showcase your expertise in statistical methodologies. Brush up on your knowledge of sample size justification, estimands, and innovative statistical methods. Be ready to discuss how you've applied these concepts in past projects, especially in regulatory submissions.
â¨Understand the Regulatory Landscape
Familiarise yourself with the regulatory requirements relevant to gene therapy and drug development. Prepare to discuss your experience with MAAs, NDAs/BLAs, and how youâve engaged with regulatory authorities. This will demonstrate your ability to navigate complex regulatory environments effectively.
â¨Communicate Complex Ideas Simply
Youâll need to explain intricate statistical concepts to non-statisticians. Practice articulating your thoughts clearly and concisely. Consider using examples from your previous work to illustrate how youâve successfully communicated complex ideas to diverse teams.
â¨Showcase Leadership and Collaboration Skills
This role requires hands-on leadership within cross-functional teams. Prepare examples that highlight your experience in managing vendors/CROs and collaborating with clinical and regulatory colleagues. Emphasise your ability to lead discussions and drive strategic decisions in a dynamic environment.