Senior Biostatistician Jobs

AB SCIENCE

Location:
France, Paris

Category:
Research and Development

Contract Type:
Employment contract

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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Senior Biostatistician