CLINICAL STATISTICIAN ( F/H)

Société d'ingénierie et de conseil en technologie, VisévoT œuvre sur les secteurs de hautes technologies en tant que partenaire de confiance de leaders industriels mondiaux du transport (aéronautique, automobile, naval, ferroviaire) et de l’énergie.

Nous collaborons avec nos clients sur l’ensemble du cycle de vie de leurs produits (de la R&D jusqu’à la maintenance).

Vous êtes passionné(e) et vous souhaitez développer vos compétences, Rejoignez VisévoT et créez le monde de demain dès maintenant au sein d’une entreprise à taille humaine partenaire des leaders industriels mondiaux !

To support one of our partners, we recruit on a permanent basis a Clinical Statistician whose mission is to provide statistical expertise and support in the development of prophylactic or therapeutic vaccines.

Primary Tasks & Responsibilities :

Responsible for a whole study from design to execution for different study designs:
• to use stat methodology to establish study strategy (eg power modelling of different scenario, set up power monitoring, set up mitigation plan to minimize risk of stat failure)
• to provide input to protocol (design, objective, endpoint, randomization strategy, sample size, stat analysis)
• to provide input to study set up (CRF review, randomization, DMP plan including specification for subset, important protocol deviation)
• to develop SAP/AAR (involving sensitivity analysis to support robustness of result) and coordinate review
• to review the TFL, to coordinate review with the stat analyst, to approve the TFL • to do the QC of the statistical analysis methodology
• to validate study specific dataset & analysis pgm specification
• to approve deviation from TFL format
• to propose SAR conclusion
• to prepare answer to study specific stat question (eg inspection, RA question)

Experience, Knowledge & Soft Skill Requirements :

• Experience in Statistics
• Good knowledge of statistical approaches applied in cancer clinical trials with a focus on survival analysis techniques,
• Comprehensive understanding of applied statistical principles and modeling in the design and analysis of clinical trials,
• Experience in statistical or clinical trial methodology research and presentations on statistical methods, clinical trial design, and analysis .

Soft Skills :
• Ability to easily communicate with different functions: clinicians, scientists, data managers, scientific writers, commercials, etc. in an international, multi-cultural environment
• Compliance with internal Standard Operating Procedures and regulatory guidelines

ICT Skills (software, operating systems, hardware, etc.) :
• Proficiency in SAS knowledge or other statistical software is an asset

Education, Methodology & Certification Requirement :

• M.Sc. or Ph.D. degree in Biostatistics with relevant experience

Place of assignment : This role is based in France, and is remotely based within Europe.
Salary and benefits package : to be negotiated