Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders. Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) for sudden sensorineural hearing loss (SSNHL).
Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases enabling it to select the best targets and modalities for drug candidates.
The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses. Sensorion has launched in the second half of 2019 two preclinical gene therapy programs aiming at correcting hereditary monogenic forms of deafness including Usher Type 1 and deafness caused by a mutation of the gene encoding for Otoferlin.
The Company is uniquely placed through its platforms and pipeline of potential therapeutics to make a lasting positive impact on hundreds of thousands of people with inner ear related disorders; a significant global unmet medical need.
Reporting to the Medical Director, the Biostatistician F/M contributes to the design and development of biostatistical methodologies used in pre-clinical, clinical, or epidemiological studies, and analyzes the figures relating to biology to extract useful information and interpret them, to help the research team make decisions.
The Biostatistician F/M is a permanent position based in Montpellier or Paris.
Implementation of studies
- Participation in thinking and working hypotheses in collaboration with doctors and the clinical project team
- Choice of a statistical model and definition of the biostatistical methodology of the clinical studies
- Determination of the study sample size
- Writing or contribution to the statistical section of the clinical study
- Validation of the statistical section of the clinical study
- Design of the statistical analysis plan
- Implementation of the experimental trial plan: methodology, evaluation criteria, hypothesis testing, randomization plans
- Validation of the evaluation criteria
- Validation of data consistency in collaboration with the Data management department of the CRO
Interpretation and dissemination of results
- Production of data reviews
- Realization and programming of analyzes
- Checking and validation of Tables, Listings and Figures generated by the statistical programs
- Writing of the statistical part of the clinical study reports
- Participation in the drafting of communication materials
- Presentation of statistical results to regulatory agencies
- Participation in the meeting with regulatory agencies
- Response to questions asked by agencies
- Carrying out a watch in order to propose new statistical tools and methodologies through scientific and technical readings
- Master or PhD in Biostatistics or equivalent
- At least 5 years of experience in a similar position
- Significant experience in a health industry: biotech, pharmaceutical industry, health industry provider, etc.
- Expertise in statistics on small sample size
- Fluent in French & English
- Understand technical or scientific documents
- Express their ideas and opinions with precision and link their interventions to those of the interlocutors
- Write about complex topics in a presentation or report, highlighting important points
- Have advanced statistical knowledge: tests, modelling, analysis of multivariate data, design of experiments…
- Master SAS software (Base, Macro, Stat, Graph)
- Master the software for analyzing programming languages, modelling, etc.
- Master the processing of complex statistical data
- Know the regulatory requirements related to their area of expertise
- Write scientific papers
- Have very good knowledge of statistics, analysis of biological data and probabilities
Position to be filled as soon as possible.