Hybrid Senior Director, Biostatistics

at Orchard Therapeutics

• Job title: Senior Director, Biostatistics
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, London, United Kingdom

About the role

• Senior Director of Biostatistics at Orchard Therapeutics leading statistical innovation for clinical drug development. Overseeing a high-performing Biostatistics team and collaborating with regulatory agencies.

Responsibilities

• Team building: Build and lead a high-performing Biostatistics team, promote collaboration and advance professional development. Develop and monitor departmental objectives. Ensure adherence to annual budget targets, including effective oversight of third-party vendors.
• Strategic leadership: Provide input into clinical development plans to ensure statistical integrity, compliance with regulatory requirements, and alignment with Orchard’s objectives.
• Cross-functional and external collaboration: Partner with clinical, regulatory, and medical affairs colleagues, and with external partners and vendors, to support the clinical development of Orchard’s assets.
• Innovation: Explore and implement novel statistical methodologies where possible, considering specific requirements for gene therapy (one time administration and long-term follow-up) and rare disease/small populations.
• Regulatory engagement: Represent Orchard as the lead statistician during interactions with global regulatory and health technology agencies. Review/contribute to regulatory briefing documents, defend the statistical integrity of regulatory submissions, and respond to technical questions from agencies.
• Study design and execution: Provide statistical input as required, including sample size justification, specification of estimands, oversight of SAP/shell production, oversight of vendors, and ensuring correct interpretation of results in study reports and submission documents.

Requirements

• 15+ years’ experience working as a statistician in drug development including significant interactions with regulatory authorities with at least 5 years in a management role.
• MSc or PhD in statistics or related discipline.
• Evidence of strategic input both at the departmental and program level.
• Excellent communication skills and in particular the ability to communicate complex statistical concepts to non-statisticians.
• Expertise in a range of statistical methodologies with practical applications (experience with rare diseases, small populations or Bayesian methodology would be an advantage).
• Prior experience of regulatory interactions, including acting as a lead statistician in regulatory submission(s).
• Prior experience as project statistician including both design and setup of a program and analysis and reporting.
• Proficiency with SAS (experience with R is an advantage); good knowledge of CDISC standards.