• Author the Statistical Sections of Protocol.
  • Propose and Review the Study design.
  • Calculate the sample size.
  • Review the Case Report Form (CRF).
  • Review the Edit Check Document (specifically for critical modules like RECIST 1.1 etc.).
  • Write the randomization specifications and coordinate and finalize all the randomization activities with the IWRS vendor.
  • Author Statistical Analysis Plan (interim and final as appropriate).
  • Perform the Statistical Analysis (Efficacy and Safety (key safety like Adverse Events)) using SAS.
  • Ensure quality of all the outputs developed.
  • Perform the role of validator as appropriate.
  • Provide Statistical Consultancy on an ongoing basis for projects.
  • Perform Futility and Efficacy analysis as appropriate for interim analysis and interact with third party independent Statistician.
  • Defend the Statistical Analysis at the IDMC meetings as appropriate.
  • Write the specifications for the efficacy analysis. Review the Specifications for the Safety Analysis.
  • Organize Data Review Meetings (equivalent to Blinded Data Review (BDR) or Dry Run) and lead all the statistical discussions.
  • Work Collaboratively with the data management, Clinical Operations, Medical Writing and the Pharmacovigilance team as appropriate.
  • Provide inputs to the regulatory affairs for all the discussions with the health authorities (e.g. ANSM, EMA, FDA).
  • Review the Clinical Study Report and provide statistical inputs as appropriate.
  • Perform exploratory analysis as appropriate.
  • Male of female with Ph.D. in Statistics with minimum 3 years of relevant pharmaceutical (or CRO) industry work experience or Masters in Statistics or equivalent with minimum 5 relevant pharmaceutical (or CRO) industry work experience.
  • Good Knowledge of SAS.
  • Good Understanding of CDISC Concepts.
  • Good understanding of ICH guidelines.
  • Fluent in English.
Additionnal informations
  • Permanent position, available immediately
  • Based in Paris
  • Salary & package to define according skills and experience