- 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.
- Permanent position, available immediately
- Based in Paris
- Salary & package to define according skills and experience