Mylene Paumier is recruiting for an Ass.Director Statistical Scientist to join a global pharmaceutical company at their site based in Switzerland on a permanent basis.
- In this challenging and dynamic role you will be global lead for the statistical strategy of multiple indications within clinical development.
- You will be responsible for the discussion and implementation of modern and innovative trial designs, statistical models, and analysis methodologies that optimize the drug development program for each indication.
- You will set the strategic direction for addressing statistical issues in regulatory submissions, and directly influence drug development decisions with internal and external partners. You may also act as SU Statistician.
- You will provide strategic statistical scientific global leadership to the clinical development programs, comprising all relevant technical and disease area knowledge
- You will drive and steer the strategic quantitative framework for (pre/early/full-) clinical programs in close collaboration with (early) project teams
- You will represent the GPT internally and externally as the statistical scientist with leading quantitative skills, including regulatory interfaces, with objective and transparent program quantitative risk/probability of success assessments
- You will define and drive statistical strategic and quantitative contributions to regulatory/submission strategy and related documents (e.g.: Target Product Profile, sPOC document, CDP, Briefing Books, Risk Management Plan and responds to HA questions)
- You will represent IIS at project level internal/external meetings with respect to statistical scientific input and in portfolio level governance boards (e.g TM forum, IFB)
- You will ensure full integration of statistical methodology, make sure that the IIS team (biometrician, data management, database programming, statistical programming, medical and scientific writing are aligned.
- You will interact with Health Authorities and external key opinion leaders as the recognized organisation expert at the program (or equivalent) level for all quantitative aspects of the program.
- PhD in Statistics (or equivalent degree/knowledge)
- Industry experience
- Experience with designing survival type studies
- Strong disease area and guidelines knowledge.
- Proven track record of developing/establishing statistical excellence. Established experience in leading global scientific improvement
For more information or to apply for this Ass.Director Statistical Scientist position, please contact Mylene Paumier on 0207 470 5672 or email: email@example.com