Senior/principal Biostatistician - Abingdon, United Kingdom - Adaptimmune

Adaptimmune

Verified Company

Abingdon, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

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.

Quantitative & Decision Sciences (QDS) is a multi-disciplinary team of data and analytics experts and scientists 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 about our patients and products.

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

Key Responsibilities

Actively contributes and represents QDS on global project and study conduct teams as a core member, requiring technical expertise, excellent teamwork, influencing and communications skills.
Oversees the statistical design, analysis and interpretation of early and late phase clinical trials including biomarker analyses and integrated analyses across trials
Deliver and QC tables, listings and figures for clinical study reports, conferences/ publications, safety reviews and regulatory requests.
Independently researches and programs statistical methodologies
Performs rolerelevant activities including (but not limited to) leading statistical contributions to the design of clinical studies; authoring statistical elements of clinical study protocols; performing sample size calculations; creating study randomizations; authoring of statistical analysis plans; performing study/integrated analyses; creation and management of functional process documentation
For assigned projects, reads protocols, analysis plans, and other key documents, as well as relevant study conduct team materials, ensuring an appropriate level of understanding in order to complete role assignments competently and efficiently, and provide supporting guidance to others both functionally and crossfunctionally

Qualifications and Experience

Substantial experience in the biotechnology, pharmaceuticals, and/or medical device industries
Postgraduate degree in Statistics or related discipline with a minimum of 3 to 5 years in a pharma/ biotech/ CRO environment
Broad knowledge, expertise and understanding of advanced statistical concepts/techniques.
Extensive programming experience using SAS
Expert knowledge and experience in clinical drug development, study and program design, clinical data integration, analysis and interpretation, regulatory submission and authority interactions
Indepth knowledge of current technical and regulatory requirements e.g., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, FDA BLA/NDA submission guidances
Demonstrated team working and roleappropriate leadership skills, while operating independently in the execution of nearly all role activities
Excellent written and verbal communications skills, and a high level of attention to detail
Proven track record for the Statistical Design, Analysis and Reporting, and Interpretation of clinical studies

Desirable

Experience and knowledge regarding trial conduct, clinical endpoints, analysis reporting, and interpretation of oncology, immunooncology, or cell therapy clinical trials
Experience using other programming languages (e.g. R)
Experience leading functional project teams, and/or line management experience
Experience developing and implementing business processes (e.g., SOPs, guidances) and training
Technical knowledge and experience in areas such as Survival Analysis, Bayesian Methods, Interim Analysis Approaches including futility, Modelling and Simulation.

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