- Experience Level
Hobson Prior are seeking a Statistics Manager to join a pharmaceutical organisation who has therapeutic technologies which are not based on biology or chemistry, however they are focused on the physical principles at nanoscale. This is an exciting new permanent role that is based in Paris.
- You will provide statistical and methodological input necessary to plan, conduct, analyse and interpret results from international development projects including NDA submission and act as a Trial Statistician for international clinical trials.
- Mentor other statisticians and provide consultancy and expert advice on statistical/methodological issues.
- Act as statistical advisor for other scientists and promote innovative statistical methods as well as efficient and harmonised clinical development processes.
- Partake in project team meetings, keep up-to-date on his/her project issues, and keep his/her supervisor informed of projects issues.
- Take on the key statistical responsibility in the planning and preparation of regulatory submissions as required.
- Represent the company in negotiations with regulatory agencies or other external decision-making bodies on statistical-methodological issues.
- Serve as a statistical consultant for other members of the department and staff members from other departments within the company.
- Maintain knowledge and awareness of developments in biostatistics and clinical trial methodology, and regulatory requirements that may impact statistical analyses.
- Serve on internal/external Data Monitoring Committees or other external committees and represent the statistical methodological expertise.
- Coordinate and participate in process improvements and interdepartmental task forces, including, implementation of revised work practices, new guidelines, and new software tools as they become available.
- Co-operate with other key scientists in planning and writing of publication.
- In depth knowledge of applicable clinical research regulatory requirements and international statistical guidelines.
- Ability to interact with authorities and external bodies on statistical and methodological issues.
- Sound knowledge of statistical methodology; ability to critique devised hypotheses and results interpretation.
- Strong working knowledge of SAS® and CDISC environment.
- Demonstrated ability to work successfully on international project teams
- Experience in regulatory interaction and negotiations with external decision-making bodies.
- Ability to supervise scientific/technical work.
- Fluent in English.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.