Full Time
London
Posted 1 month ago

We are looking for an experienced Principal Statistician with a drug development background to support our multi-speciality clinical development team. The Principal Statistician will be responsible for providing expert technical guidance and input to the development programs with fellow project team members.

COMPASS Pathways is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health (https://compasspathways.com/). Our first major initiative is developing psilocybin therapy for patients with treatment-resistant depression. 

Location : The role is based in the United Kingdom.

Reports to: The Principal Statistician will report to the Director of Statistics.

Roles and responsibilities:

Study design

  • Develop statistical methods sections of protocols and statistical analysis plans
    • Evaluation of outcomes
    • Sample size calculation
    • Randomisation
    • Estimand derivation
  • Simulations of outcomes
  • Evaluation of novel outcomes
  • Method and outcome development

Study data evaluation

  • Analysis of efficacy, safety, PK data
  • Exploratory, post-hoc analyses to generate new ideas
  • Oversight of Clinical Study Report development
  • Involvement in data dissemination
  • Development of creative and scientifically sound ways to display data

External evaluations

  • Screening of new opportunities
  • Due diligence
  • Evaluation of results from studies and programs outside COMPASS Pathways

Regulatory activities

  • Preparation of new analyses for regulatory purposes
  • Contribution to language in key regulatory documents
  • Participation in face to face regulatory interactions

Profile:

  • The ideal candidate should have an MSc or preferably a PhD in a related discipline with a considerable statistical component (e.g. Biostatistics, Medical Statistics, Mathematics)
  • Drug development background and experience of design, analysis and reporting of clinical studies
  • Should be able to contribute not only to clinical activities but also to the design and evaluation of preclinical projects (including evaluation of external opportunities)
  • Prior regulatory experience would be a clear advantage
  • Proficient at conducting analyses in SAS
  • Focused on solving challenging problems and good communication and team work skills

Equal opportunities

We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability.

Job Features

Job Category

Medical

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