Associate Director, Statistical Programming
Adaptimmune Therapeutics PLC
Location
Abingdon, Oxfordshire | United Kingdom
Job description
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialisation 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.
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, 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 blended Programming role encompasses responsibilities as both a functional leader and senior project resource supporting Clinical Development, Enterprise Data & Analytics, and QDS activities, facilitating the success of projects and teams.
Key Responsibilities
- When in the business role of Programming Group Leader (PGL), leads, manages, and develops a group of statistical programmers across one or more Clinical Development or QDS projects, and facilitates Programming resourcing decisions across project teams
- Provides expert advice and leads/contributes to Adaptimmune’s responses to complex issues in statistical programming, health authority submissions and responses, and clinical data standards
- Contributes to Enterprise and Clinical teams to develop, implement, and champion standards for Adaptimmune's data collection, integration, analysis, and reporting
- Contributes to defining strategic objectives related to statistical programming, clinical data flows and standards, and associated technology, for inclusion into QDS's annual business objectives
- Across the business areas in which s/he operates, strives to create clarity for QDS team members and cross-functional partners/customers regarding shared challenges, roles and responsibilities, problem-solving approaches, processes, success factors, and risk and impact assessments
- Is an enterprise champion for Adaptimmune achieving and furthering our target data culture, and for self and within teams, promotes and practices data-driven decision making
- Drives implementation, development, and adoption of Adaptimmune and industry best practices relevant to own role, cross-functional project teams, and the broader QDS function, and ensures good data and knowledge stewardship and inspection readiness on all assigned activities, as well as for team-level activities
- Leads and contributes to development and maintenance of Programming and QDS onboarding and training, and contributes knowledge, insights, and hands-on leadership/support to continuous improvement and lessons learned efforts intended to enhance Adaptimmune's quality, efficiency, and effectiveness
- For QDS, cross-functional, and company initiatives, champions their adoption and success, and when assigned, leads or contributes as a project team resource
- Stays informed of current and upcoming technical and regulatory requirements/guidance, ensures own efforts adhere to applicable Adaptimmune and external requirements, and strives to create clarity for others on those requirements in the context of project team activities
- At all times, ensures personal decisions, actions, and behaviors are consistent with Adaptimmune's values and Code of Conduct
Qualifications & Experience
Required
- 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
- Line management experience, or experience leading large, global, cross-functional, and/or multidisciplinary teams
- Extensive experience leading functional project teams within a cross-functional or matrix project environment
- Experience developing, maintaining, or delivering functional training
- Expert, role-relevant knowledge and experience in clinical drug development, data integration and analysis, and submissions to global health authorities and payers
- Extensive statistical programming experience using SAS (especially BASE, STAT, GRAPH) for database creation, database integration, analysis, visualization, and reporting of clinical trial data
- Expertise in clinical data standards (e.g., CDASH, SDTM, ADaM), their practical applications in clinical trials and preparing compliant health authority submissions, as well as substantial knowledge of their associated lifecycle management and cross-functional governance
- Extensive knowledge of current technical and regulatory requirements related to the role
- Experience developing and implementing business processes (e.g., SOPs, guidances)
Desirable
- Experience in pulling through new, innovative approaches from idea to implementation, and developing understanding of, or solutions for, complex, unstructured challenges
- Experience performing end-to-end software and/or systems development and lifecycle management
- Experience and knowledge regarding trial conduct, clinical endpoints, and analysis and reporting of oncology, immuno-oncology, or cell therapy clinical trials
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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