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Principal Biostatistician (Director)

Primary Responsibility

The Principal Biostatistician will have a meaningful impact on clinical projects, interact directly with scientists and clinicians across the company and externally, be a core member of multi-disciplinary teams and with the VP of Biometrics, and help shape the evidence generation strategy across clinical development.

 

Key Responsibilities

  1. Directs and leads the statistical input for more than one disease indication, including review with Research and Development management.
  2. Oversees the statistical design, analysis and interpretation of Phase 1-4 clinical trials including biomarker analyses and integrated analyses across trials
  3. Actively contributes to global project and study teams as a core member
  4. Management of UK based Data Manager and SAS Programmer.  Partner with Clinical Monitoring to ensure high quality data sets
  5. Represents department in meetings with regulatory agencies and investigators
  6. Seeks advice from internal and external statistical experts in areas outside of expertise
  7. Researches and programs statistical methodologies such as Bayesian approaches, interim analyses including futility
  8. Provides SAS programming support for clinical studies to support the development, regulatory approval and conferences/publications for Adaptimmune T-cell therapies
  9. Deliver tables, listings and figures for conferences, publications, safety reviews and regulatory requests.

 

Qualifications & Experience

Required

•  Master’s degree / PhD  in Biostatistics or Statistics coupled with extensive experience in a pharma/ biotech/ CRO.

•  Extensive knowledge of SAS and other programming languages

•  Proven track record of Statistical Design, Analysis and Reporting, and Interpretation of clinical studies

•  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

 

Skills & Competencies

Required

•  Delivery oriented.

•  Works well under pressure and on multidisciplinary, virtual teams

•  Works independently - self-directed, high energy and strong work ethic.

•  Excellent written and verbal communication skills

•  Ability to adapt effectively to changing priorities

•  High degree of creativity, latitude and attention to detail required.

•  Demonstrates strong project management, teamwork, and interpersonal skills.

 

 

 

 

 

 

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