This is a senior role in the Biometrics team and a key role on Project Teams and Study Conduct Teams requiring deep technical expertise, excellent teamwork within Biometrics. Strong partnership, influencing and communications skills with partners across Early and Late Phase Clinical Development. The Biometrics team remit is to support strategic data governance, study design, data management, data integration, data analytics and statistical analyses to explore emerging scientific and medical hypotheses and provide quality controlled tables, listings and figures for the evaluation of efficacy, safety and biomarkers to support conference, publications, regulatory submissions, and internal decision making. The Biometrics team aims to create insights and information from data using a range of data analytics and data visualization approaches and tools. The candidate will work collaboratively with diverse functional groups within Adaptimmune and contribute to the Biometrics Strategy across the portfolio.
- Directs and leads the statistical input for more than one disease indication, including review with Research and Development management.
- Oversees the statistical design, analysis and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
- Previous experience leading or co-leading a submission project (planning and anticipating post submission needs)
- Previous leadership responsibilities to other programming team members to deliver high quality submission ready content.
- Actively contributes to global project and study teams as a core member
- Partners with Data Management, SAS Programmers and Clinical Monitoring to ensure high quality data sets
- Represents department in meetings with regulatory agencies and investigators
- Seeks advice from internal and external statistical experts in areas outside of expertise
- Researches and programs statistical methodologies such as Bayesian approaches, interim analyses including futility
- Provides SAS programming support for clinical studies to support the development, regulatory approval and conferences/publications for Adaptimmune T-cell therapies.
- Deliver tables, listings and figures for conferences, publications, safety reviews and regulatory requests.
- Master’s degree in Biostatistics or Statistics with a minimum of 3 to 5 years in a pharma/ biotech/ CRO (preferred) industry or Master's degree with a minimum of 10 years of experience in a pharma/ biotech/ CRO environment. PhD preferred
- Extensive knowledge of SAS and other programming languages; able to provide samples of programming upon request.
- Proven track record of Statistical Design, Analysis and Reporting, and Interpretation of clinical studies
- Regulatory Submission experience.
- Oncology Experience.
- Broad knowledge, deep expertise and superior understanding of advanced statistical concepts and techniques.
- Experience working with clinicians, scientists, regulators and presenting at statistical and investigator meetings
- Delivery oriented.
- Works well under pressure and on multidisciplinary, virtual teams
- Strong team player who collaborates at all levels of the matrix within Biometrics and on Study Conduct Teams.
- Works independently - self-directed, high energy and strong work ethic.
- Delivery oriented, able to work quickly, independently and ensure high quality.
- Excellent communication (both written and verbal) and excellent relationship building skills.