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Senior Biostatistician

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AB SCIENCE

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Location:
France , Paris

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Category:
Research and Development

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

Job opportunity for a permanent, onsite Senior Biostatistician role in Paris, France. The role involves statistical responsibilities, collaboration with multiple teams, and regulatory input.

Job Responsibility:

  • 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:

  • 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
What we offer:
  • Permanent position
  • Salary & package to define according skills and experience

Additional Information:

Job Posted:
December 01, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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