Senior Biostatistician

il y a 7 jours

Paris e, France Venn Life Sciences Temps plein

Overview of the role:Venn Life Sciences (part of the hVIVO Group) is an Integrated Drug Development partner offering a unique combination of drug development consultancy, clinical trial design expertise and biometry activities. Venn’s capabilities and expertise include: CMC, Non-Clinical, Clinical Development, Biometry and Regulatory Affairs. We have dedicated operations in France, the Netherlands and the UK.

Venn Life Sciences biometry Services offers a unique set of high quality, innovative data management and biostatistics services utilizing new technologies and expertise to help our Sponsors have access to their data faster and at a lower cost. We work in partnership with our customers to scientifically contribute to the clinical development plans.

We are currently seeking a **Senior Biostatistician **to join our team. Biostatistics activities are based in Paris, France. Ideally the position will be part-time office-based in the Paris office, part-time homebased. The position will report to the Head of Biostatistics.
Main Responsibilities & duties**:Responsibilities**:

- Sample size calculation
- Clinical trial design and hypothesis development
- Statistical section of the protocol/synopsis writing
- Support client’s projects/internal teams on Methodology and Biometric sciences
- Collaborate with Biometrics/Methodology Consultant on specific projects
- Statistical Analysis Plan writing
- CRF Review
- Programming (ADS, TFLs, specifications)
- Review and validation of statistical results
- Data-review meeting (preparation, attendance)
- Statistical report writing
- Statistical section of the clinical study report writing/review
- Guarantee quality and compliance with regulatory standards of the statistical analysis from study design to reporting
- Collaborate and work harmoniously with other departments in Venn Life Sciences
- Deliver high quality output in accordance with the timelines and budget parameters set by the Project manager and Head of Biostatistics

Skills & Experiences**:Skills**:

- Higher education (Master Degree or PhD) in statistics applied to health or biometrics;
- Good knowledge of statistical science and biometrics
- Knowledge on clinical trial methodology and regulatory standards (ICH, FDA, EMA, CDISC )
- At least 4 years’ experience as a Biostatistician in a CRO, pharma, or biotech
- Meticulous and skilled in analysis and organization
- Strong interpersonal skills and ability to communicate effectively at all levels in and outside the company
- Proficient in SAS and optionally other specialized statistical packages
- Fluent verbal and written English.

*
How to ap**ply**:
**Job Type**: Permanent

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