|Job title :||Principal Biostatistician|
|Job type :||Permanent|
* Providing statistical support and input to the design and analysis of clinical studies.
* Responsible for the quality and timelines of all statistical and programming deliverable for assigned
* clinical studies, including studies for which statistical activities are outsourced to CRO partners.
* Ensuring timely availability of complete, accurate and consistent analysis results to support decision making
* Working as a key member of the clinical study team.
Your main responsibilities:
* Provide statistical input to the design, analysis and interpretation of clinical studies
* Author statistical sections of protocols and statistical analysis plans
* Ensure provision of quality and timely statistical analyses results that support quality and timely decision making
* Lead statistical and programming study teams and perform statistical analyses
* Coordinate and provide statistical oversight for outsourced studies, ensuring CROs accountability for the quality of their deliverable
* Represent statistics within cross functional study teams and provide statistical support and solutions
* Assist with in interactions with health Authorities
* Maintain current scientific and regulatory knowledge
* Provide input/lead internal process improvement
* Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs.
* MSc. or PhD in statistics or related field
* Minimum of 4 years' experience as project/study statistician in Clinical Development in the pharmaceutical industry or CRO
* Strong statistical methodology knowledge and applications.
* Experience using Bayesian designs is a plus
* Excellent programming skill in SAS. Experience using R is a plus
* Good experience using CDISC standards
* Up to date knowledge of regulatory requirements related to statistics
* Good communication skills and ability to build positive relationships
* Fluent in English
To apply reach out:
TEL: +33 1 70 80 74 89