Senior/Principal Statistician
About Us
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.
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.
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 role-relevant 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.
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
- In-depth 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 role-appropriate 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.
How to apply:
Go to UK Careers :: Adaptimmune Therapeutics plc (ADAP) or you can contact Debbie Finer on Debbie.Finer@adaptimmune.com