Biostatistician

**Adaptimmune is a leader in TCR T-cell therapy, focused on designing and delivering novel cancer immunotherapy products. We utilize the body’s own machinery - the T-cell - to target and destroy cancer cells. We believe our therapies have the potential to significantly impact cancer treatment and clinical outcomes. Our company culture is rooted in trust, our capacity to collaborate, and being honest and brave in our desire to successfully transform the lives of people with cancer. It is this formula that enables us to face challenges and take advantage of opportunities in our fight against cancer.**

Quantitative & Decision Sciences (QDS) is a multi-disciplinary team of data and analytics experts who drive purpose and consistency in how Adaptimmune collaborates and makes decisions through data. By Unlocking the value of our data, enabling analytics insights, and anticipating future needs, QDS optimizes identifying and answering the most important questions for our patients and products.

Within QDS, Biostatistics is the business unit that leads statistical design, analysis, and interpretation activities, while protecting trial integrity and ensuring data-driven decision making across Adaptimmune's Clinical Development programs.

This role is a functional team member supporting Biostatistics activities on assigned Clinical Development, Enterprise Data & Analytics, and QDS projects, including contributions to milestone planning and delivery, data and knowledge stewardship, and inspection readiness.

**Key Responsibilities**
- Typically assigned as a team member on multiple, concurrent studies/projects, with occasional leadership of a workstream or set of activities within a larger study/project team
- When deployed to a project/study team, operates under the leadership, direction, and oversight of a Product Lead Biostatistician, Study Lead Biostatistician, other project lead/delegate
- Performs role-relevant activities including (but not limited to) authoring or contributing to statistical elements of clinical study protocols; performing sample size calculations; creating study randomizations schemes; leading or contributing to authoring or validation of statistical analysis plans for studies and integrated analyses; authoring and/or critical review of functional specifications and other documents; contributions to data curation and quality; creation and management of functional process documentation; attendance and active engagement at project team meetings; and role-appropriate contributions to applicable cross-functional team activities
- If assigned as a business owner for a QDS process, system, or tool, provides business leadership for its development, deployment, adoption, lifecycle management, and support, in close collaboration with enabling functions (e.g., Information Management, Compliance), as appropriate
- In a timely manner for assigned projects, reads protocols, analysis plans, and other key documents, as well as relevant team materials (e.g., kickoff meeting slides, meeting minutes, communication and risk management plans) and guidance on team practices and norms, ensuring an appropriate level of understanding in order to complete role assignments competently and efficiently, typically with supporting guidance and calibration from her/his project lead, line manager, or other senior functional team member
- Proactively ensures quality of her/his own work and completeness and accuracy of applicable quality and process documentation
- Regularly maintains an understanding of documented risks, issues, and mitigations at the functional and project level, raises potential risks and issues in a timely manner to project and functional leadership, and contributes knowledge and takes practical action on the management and mitigation of such items
- As needed, represents QDS and project/study teams at internal and external meetings, including audits and inspections

**Qualifications & Experience**
- Postgraduate degree in Statistics or related discipline
- Knowledgeable about the biotechnology and/or pharmaceuticals industries
- Knowledgeable about clinical drug development, study design considerations, clinical data integration, analysis, and interpretation, and regulatory submissions topics relevant to the role
- SAS and/or R programming knowledge and experience to a competent level
- Awareness of current technical and regulatory requirements applicable to the role - e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines

imzQyiCwUq