Director, Biostatistics in City of Westminster

The Senior Director, Biostatistics is the head of Orchard's Biostatistics function and a key member of the Medical/Clinical Development team, working to provide transformative gene therapies to patients.

This role provides a unique opportunity to contribute strategic statistical thinking to clinical drug development across multiple programs, in a dynamic environment.

You will be the primary voice for statistical innovation, ensuring that our gene therapy candidates are evaluated using the most robust and efficient methodologies available.

This role requires a blend of deep technical expertise and the presence to interact effectively with both internal stakeholders and global regulatory agencies.

The position will report to the VP, Clinical Science and will have management responsibility for a team of statisticians and programmers.

Key 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.
• 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 Ph D 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.

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.

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