Job Description

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

Key Responsibilities

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

Desirable

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.

Valid through: 4/21/2021