Senior Biostatistician M/F

Responsibilities

• 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 or 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.
• Based in Paris
• Salary & package to define according skills and experience