Senior Biostatistician M/F

AB Science; Paris; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

A pharmaceutical company based in Paris is seeking a Statistical Analyst to author protocol sections, perform statistical analyses using SAS, and provide consultancy on projects. Candidates should have a Ph.D. in Statistics with 3 years of experience, or a Master's with 5 years. Knowledge of CDISC concepts and ICH guidelines is essential. Competitive salary based on skills and experience.

Qualifications

• Minimum 3 years of experience in the pharmaceutical industry for Ph.D. holders.
• Minimum 5 years of experience for Master's degree holders.
• Good knowledge of SAS and understanding of CDISC concepts.

Responsabilités

• Author the Statistical Sections of Protocol.
• Propose and Review the Study design.
• Perform the Statistical Analysis using SAS.
• Review the Case Report Form (CRF).
• Review the Edit Check Document for key modules.
• Write randomization specifications and coordinate IWRS activities.
• Author Statistical Analysis Plan (interim and final).
• Perform Statistical Analysis (efficacy and safety) using SAS.
• Ensure quality of all outputs; act as validator.
• Provide ongoing statistical consultancy for projects.
• Defend analyses at IDMC meetings and interact with external statisticians.
• Write efficacy and safety analysis specifications.
• Organize Data Review Meetings and lead statistical discussions.
• Collaborate with data management, Clinical Operations, Medical Writing, and Pharmacovigilance.
• Provide regulatory input for discussions with health authorities.

Connaissances

Statistical analysis

SAS

CDISC concepts

ICH guidelines

Formation

Ph.D. in Statistics

Masters in Statistics

Description du poste

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