The Associate Director of Biostatistics will help shape the evidence generation strategy across Adaptimmune’s Clinical Development. This role will be responsible for developing study protocols and statistical analysis plans, delivering statistical analyses and reports and supporting regulatory dossiers and meetings, scientific presentations, and publications by:
- Representing Biostatistics and actively contributing to project and study teams
- Acting as a cross-functional business partner to data managers, scientists, clinicians and external collaborators such as investigators and CROs
- Lead the statistical input for more than one disease indication, including review with Research and Development management.
- Actively contribute to global project and study teams as a core member
- Research and program statistical methodologies such as Survival Analysis, Bayesian approaches, Interim Analyses including Futility
- Be accountable and responsible for the statistical design, analysis, reporting and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
- Contribute to the statistical design of studies, write the SAP and mock TFLs, contribute to the CSRs.
- Manage and review CRO deliverables
- Drive and oversee CDISC implementation for oncology trials.
- Partner with Data Management and SAS Programmers to ensure high quality clinical trials databases and analysis data sets
- Represents department in meetings with regulatory agencies and investigator.
- Builds/maintains a strong network of external statistical experts
Qualifications and Experience
- PhD or (MS) in Biostatistics or Statistics with a minimum of 6 (or 8) years of pharmaceutical, CRO or biotechnology industry experience
- Experience supporting oncology trials is required
- Demonstrated experience leading regulatory submissions across multiple trials and indications
- Broad knowledge deep expertise and superior understanding of advanced statistical concepts and techniques
- Experience in leading statistics on a Regulatory submission using CDISC standards
- Able to ‘think on your feet’ and work in a fast-paced, innovative, delivery-oriented environment
- Extensive knowledge of SAS and R Programming experience
- Proven track record of Statistical Design, Analysis and Reporting, and Interpretation of clinical studies
- Experience working with regulators and presenting at statistical and investigator meetings
- Works well under pressure and on multidisciplinary, virtual teams
- Works independently - self-directed, high energy and strong work ethic.
- High degree of creativity, latitude and attention to detail required.
- Excellent oral and written communication skills.