Lead Biostatistician

STATERA; France; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

STATERA Biometry is seeking a Lead Biostatistician to drive statistical leadership across clinical studies and project teams. You will design trials, review critical documents, and coordinate statistical activities to meet timelines and deliverables.

The role requires a PhD in Statistics or Biostatistics with 8+ years in pharma/CRO settings, strong SAS/R skills, CDISC knowledge, and proficiency in English. You will collaborate with regulatory teams and contribute to publications and

Qualifications

• PhD in Statistics, Biostatistics or related quantitative field (Master’s/engineering degree).
• Significant experience in clinical development, including involvement in clinical studies.
• Experience contributing to regulatory submissions and interactions.
• Strong knowledge of SAS and R.
• Good understanding of international clinical and regulatory guidelines.
• Knowledge of CDISC standards.
• Full professional proficiency in English.

Responsabilités

• Providing statistical expertise to clinical study and project teams
• Contributing to the design of clinical trials and reviewing key study documents (protocols, SAPs, randomization specifications, etc.)
• Coordinating and overseeing statistical activities as timelines and deliverables
• Supporting the interpretation of study results in close collaboration with clinical teams
• Contributing to the preparation of regulatory documents, scientific communications and publications

Connaissances

Statistical expertise

Clinical development

Project coordination

Formation

PhD in Statistics

Outils

SAS

R

CDISC standards

Description du poste

STATERA Biometry is looking for a Lead Biostatistician.

Your responsibilities will include:

• Providing statistical expertise to clinical study and project teams
• Contributing to the design of clinical trials and reviewing key study documents (protocols, SAPs, randomization specifications, etc.)
• Coordinating and overseeing statistical activities as timelines and deliverables
• Supporting the interpretation of study results in close collaboration with clinical teams
• Contributing to the preparation of regulatory documents, scientific communications and publications

Your Profile :

We are looking for a Lead Biostatistician with at least 8 years of experience in the pharmaceutical industry and/or CRO environment.

• A PhD in Statistics, Biostatistics or a related quantitative field (Master’s degree, engineering degree)
• Significant experience in clinical development, including involvement in clinical studies
• Experience contributing to regulatory submissions and interactions
• Strong knowledge of SAS and R
• Good understanding of international clinical and regulatory guidelines
• Knowledge of CDISC standards
• Full professional proficiency in English