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Director, Biostatistics and Clinical Informatics

SUMMARY

The Director of Biostatistics and Clinical Informatics’ mission will be to 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:

  • Managing Biostatisticians and Programmers
  • Representing Biometrics 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, manage and mentor your team in tackling high priority/cross-functional needs.
  • Direct and 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 and the safety review team as a core member
  • Research and program statistical methodologies such as Bayesian approaches, interim analyses including futility
  • Be accountable and responsible for the statistical design, analysis and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
  • Set up, oversee, manage and review CRO deliverables
  • Drive and oversee CDISC implementation for oncology trials.
  • Partner with Data Management to ensure high quality clinical trials databases and analysis data sets
  • Represents department in meetings with regulatory agencies and investigators; data safety monitoring boards; IDMC statistician and SDAC.
  • Builds/maintains a strong network of external statistical experts

 

QUALIFICATIONS & EXPERIENCE

  • PhD in Biostatistics or Statistics with a minimum of 8 years of pharmaceutical, CRO or biotechnology industry experience
  • Experience supporting early stage oncology trials is required
  • Demonstrated experience leading, managing, and developing employees
  • Broad knowledge, deep expertise and superior understanding of advanced statistical concepts and techniques
  • Experience in the Regulatory submission of datasets using CDISC standards
  • Able to ‘think on your feet’ and work in a fast-paced, innovative, delivery-oriented environment
  • Extensive knowledge of SAS and other programming languages preferred
  • 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.
  • Demonstrates strong project management, teamwork, and interpersonal skills.

 

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