Adaptimmune Principal Biostatistician in Philadelphia, Pennsylvania
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.
PhD in Biostatistics or Statistics with a minimum of 5 years in a pharma/ biotech/ CRO (preferred) industry or Master's degree with a minimum of 8 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.
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
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.