Senior Biostatistician M/F

AB SCIENCE

Paris

EUR 100 000 - 125 000

Description du poste

Responsabilities

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.

Requirements

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