Senior Biostatistician & Biometrics/Methodology Consultant
Based in Paris but can be remote in France.
Venn Life Sciences (part of the Open Orphan 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 includes: CMC, Non-Clinical, Clinical Development, Biometry, Randomization and Regulatory Affairs. We have dedicated operations in France, the Netherlands and the UK.
Venn Life Sciences biometry offers a unique set of high quality, innovative data management and biostatistics services utilising 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 & Biometrics/Methodology Consultant to join our team. Biostatistics activities are based in Paris, France. Ideally the position will be officed-based in the Paris office, part-time homebased activity can be considered according to profile/experience. The position will report to the Head of Biostatistics.
Project/Study statistician activities:
- Sample size calculation
- Clinical trial design and hypothesis development
- Statistical section of the protocol/synopsis writing
- 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
Biometrics/Methodology Consultant activities:
- Support client’s projects on Methodology and Biometric sciences
- Methodological and Statistical advice and support to clients in project development (Clinical Development Plans, Protocols) and interaction with Regulatory Authorities
- Methodological and Statistical support to internal teams in Study Design activities (Synopsis, Protocol, Statistical Analysis Plans) and Statistical Activities (Sample size calculations, Statistical analyses and reporting)
- Scientific and regulatory intelligence regarding new statistical methods and new regulatory guidance. Propose relevant improvement in biometry processes
- Training activities on methodological and statistical topics (both internally and to clients)
The successful candidate will have:
- Higher education (Master Degree or PhD) in statistics applied to health or biometrics;
- Expert knowledge of statistical science and biometrics (frequentist and Bayesian methods, statistical modelling, computer simulations…)
- Expert 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; ideally with previous exposure to consulting activity and/or regulatory environment
- 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 other specialized statistical packages (R, WinBugs, Stan…)
- Fluent verbal and written English.
Salary will be in accordance with skills and experience.
How to apply:
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE MAY NOT BE ABLE TO REPLY TO CANDIDATES WHOM WE DO NOT INVITE FOR INTERVIEW
We do not require the services of agencies for this role.