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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 opportunities for professional growth.
- Other info: Be part of a diverse and inclusive team committed to equality and innovation.
- Why this job: Make a real impact on patients' lives through groundbreaking gene therapies.
- Qualifications: 8+ years in drug development, MSc/PhD in statistics, and strong communication skills.
The predicted salary is between 48000 - 72000 £ 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 hands‑on leadership role within a cross‑functional 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.
Education / 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).
- Hands‑on experience with SAS (experience with R is an advantage); good knowledge of CDISC standards.
Equal Opportunity Statement
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.
Notice to All Applicants
Orchard Therapeutics participates in E‑Verify.
RECRUITERS
All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.
Director, Biostatistics in London employer: Orchard Therapeutics
Contact Detail:
Orchard Therapeutics Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Biostatistics in London
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend events, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to biostatistics. Think about how your experience aligns with the role and be ready to share specific examples that showcase your skills.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you, like Orchard Therapeutics! Tailor your approach and show genuine interest in their mission and values when you reach out.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Plus, it shows your enthusiasm for the position and the company.
We think you need these skills to ace Director, Biostatistics in London
Some tips for your application 🫡
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 highlight your communication skills in your application. We love candidates who can bridge the gap between data and decision-making!
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 shows you’re keen on joining our team!
How to prepare for a job interview at Orchard Therapeutics
✨Know Your Stats Inside Out
As a Director of Biostatistics, you’ll need to demonstrate your expertise in statistical methodologies. Brush up on your knowledge of sample size justification and estimands, as these will likely come up during the interview. Be ready to discuss how you've applied innovative statistical methods in past projects.
✨Showcase Your Regulatory Experience
Since this role involves significant interaction with regulatory authorities, prepare to share specific examples of your experience with regulatory submissions. Highlight any successful MAAs or NDAs you've been involved with, and be prepared to discuss how you’ve addressed questions from regulatory bodies in the past.
✨Communicate Complex Concepts Simply
You’ll need to explain complex statistical concepts to non-statisticians, so practice articulating your thoughts clearly and concisely. Consider preparing a few examples where you successfully communicated intricate ideas to diverse audiences, showcasing your ability to bridge the gap between statistics and clinical development.
✨Demonstrate Leadership and Collaboration Skills
This role is hands-on and requires collaboration with various teams. Prepare to discuss your leadership style and how you’ve effectively managed cross-functional teams in the past. Think of examples where you’ve led projects, managed vendors, or contributed to risk management, as these will illustrate your operational oversight capabilities.