Principal Biostatistician - HTA

Warman O’Brien

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

As an exceptional HTA Principal Biostatistician (Late Phase) you will working for a forward-thinking Global Biopharma company with a promising pipeline including several novel molecules. They have an extremely innovative culture where you matter, and that encourages people to bring forward new ideas.

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 experience and skills in RWE, NIS studies and contribution to HTA dossiers and Medical Affairs.

Desirable Experience;
  • Working on submissions and post submissions
  • Working knowledge and understanding the HTA/RWE/Medical Affairs environment
  • Act as lead biostatistician for one or more clinical studies within a clinical program or across multiple clinical programs.
  • Participates in the protocol summary development. Give input into the study design, efficacy and safety parameters and the planned statistical analyses.
  • Author the Statistical Analysis Plan (SAP) or reviews and approve the SAP if prepared by an external partner biostatistician.
  • Coordinate with other internal or external biostatisticians and statistical programmers to prepare the statistical analyses. Communicate and coordinate all statistical activities with external partner biostatisticians.
  • Review the clinical study report and provide input on interpretation of results by attending the Results Interpretation Meeting (RIM).
  • Assist the biostatistician lead for a program of studies with the statistical deliverables for regulatory submissions and the lifecycle of a development compound.
What do you get in return?
  • Working a friendly, innovative small group
  • Excellent opportunities to develop and grow
  • Home working flexibility
  • Industry leading salary, annual bonus, car allowance and Long Term Incentive Plan
What to do next: If this opportunity is of interest, please apply now with your CV as the organisation are looking to welcome the new Statistician onboard as soon as possible.

Not what you're looking for? Please contact Aimee Weston on 07806 790645 for a confidential discussion about potential opportunities.

Warman O’Brien