Principal Biostatistician (Late Phase)

Warman O’Brien

  • Bruxelles
  • CDI
  • Temps-plein
  • Il y a 4 mois
Job Description

Our client is looking for a Principal Biostatistician (office based, with the possibility to be home based 3 days per week) to join their experienced and expanding team. They are a leading, global pharmaceutical with an exciting pipeline across a number of therapeutic areas including immunology and neurology.

The role is a Lead Biostatistician role responsible for one or more individual clinical studies within a clinical program or across multiple clinical programs. You will be required to provide statistical input to clinical studies, including input into the study design through statistical analysis and reporting. This requires someone with skills and interest in overseeing a CRO to conduct Phase III and Follow-up trials

Location:

Office based with the option of being home-based 3 days per week.

They offer:
  • Competitive salary
  • Flexible working options
  • Very competitive benefits package
  • Excellent career development opportunities
Role Responsibilities:
  • Acts as the lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.
  • Works very closely with the other biostatisticians and the program-level biostatistician and the lead biostatistician at the assigned CRO or other vendor.
  • Participates in the protocol summary development. Gives input into the study design, efficacy and safety parameters and the planned statistical analyses .
  • Authors the Statistical Analysis Plan (SAP) or reviews and approves the SAP if prepared by an external partner biostatistician.
  • Coordinates with other internal or external biostatisticians and statistical programmers to prepare the statistical analyses. Communicates and coordinates all statistical activities with external partner biostatisticians.
  • Reviews the clinical study report and provides input on interpretation of results by attending the Results Interpretation Meeting (RIM).
  • Assists the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
Person Specification:
  • Excellent understanding of SAS computing package.
  • Able to manage multiple tasks and projects.
  • Advanced statistical analysis skills.
  • Good clinical studies design and analysis experience.
  • Demonstrated experience in leading and participating in collaborative work teams at local and global levels, preferably including CROs.

Warman O’Brien