Adaptimmune Therapeutics PLC
Location
Abingdon, Oxfordshire | United Kingdom
Job description
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Within QDS, Programming is the business unit that oversees and delivers statistical and scientific programming contributions in support of Clinical Development portfolio delivery, regulatory submissions, internal decision making, exploratory reporting and analysis, and enterprise data flows.
Primary Responsibility
This role is a senior functional resource who serves as the Programming leader for one or more Clinical Development, Enterprise Data & Analytics, or QDS projects, ensuring all aspects of Programming activities supporting the success of those projects, including guidance, decision-making, and contributions to milestone planning and delivery, data and knowledge stewardship, and inspection readiness.
Key Responsibilities
- Typically serves as project/study leader and occasionally as team member, supporting multiple, concurrent projects across those roles
- When deployed as a project/study team member, operates under the leadership, direction, and oversight of a Product Lead Programmer, Study Lead Programmer, other project lead/delegate; and when assigned as a project/study team leader, provides team direction and oversight to ensure consistently positive quality and delivery outcomes, strives for transparent and efficient resource utilization, and proactively manages stakeholders' expectations
- Performs role-relevant activities including (but not limited to) creation or validation of analysis, reporting, database, visualizations, and other statistical and scientific programming deliverables; 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
- When assigned as a team leader, performs role-relevant activities including (but not limited to) creation and maintenance of study/project delivery plans, timelines, assumptions, and dependencies; development and maintenance of Programming functional resource demand estimates and utilization by resource, activity, and time period; identification, reporting, monitoring, mitigation, and escalation of risks and issues potentially impacting the team or function; clearly communicating, updating, and maintaining team members' assignments; regularly tracking and monitoring team member and overall progress toward project objectives; and regular and clear reporting of project status to functional and cross-functional leadership and other stakeholders
- 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, and provide supporting guidance to others both functionally and cross-functionally
- Proactively ensures quality of her/his own work and completeness and accuracy of applicable quality and process documentation, accountable for these elements at a team-level when assigned as leader of a study/project team, and actively partners with QDS and cross-functional leaders to improve quality outcomes
- Understands and analyzes 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, plays a key role in identifying and interpretating new risks, and contributes knowledge and ensures practical action on the management and mitigation of such items at both the individual and team leader ship levels
- As needed, represents QDS and project/study teams at internal and external meetings as a senior functional expert, including audits and inspections
qualification & Experience
- Undergraduate degree in mathematics, statistics, engineering, computer science, or life or social sciences (graduate degree preferred)
- Extensive experience in the biotechnology and/or pharmaceuticals industries
- Expert, role-relevant knowledge and experience in clinical drug development, data integration and analysis, and regulatory and payer submissions
- Extensive statistical and/or scientific programming experience using SAS (especially BASE, STAT, GRAPH), R, and/or other relevant programming languages for database creation, database integration, analysis, visualization, and reporting of clinical trial or other scientific data
- Expertise in clinical data standards (e.g., CDASH, SDTM, ADaM), their practical applications in clinical trials and preparing compliant regulatory submissions, as well as strong working knowledge of their associated lifecycle management and cross-functional governance
- Extensive knowledge of current technical and regulatory requirements related to the role
- Substantial experience leading functional project teams within a cross-functional or matrix project environment
- Willingness to travel 25%
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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