Ass. Director Bio-statistics - Innovative company - ONCOLOGY
3 days left
- Experience Level
- Experienced (non-manager)
My client is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from haematological malignancies and solid tumours. They have built a deep clinical and research pipeline of therapies for the treatment of cancers with significant unmet need. The Company has multiple antibody drug conjugates in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical antibody drug conjugates in development.
My clients has recently successfully completed an initial public offering (IPO) which initiated its commercial organization to build the pre-launch market activities. They have operations in Lausanne Switzerland, Londen, New Jersey US and San Francisco US.
As Associate Director in statistics you will be responsible for statistical activities in support of clinical trials in Europe and report to Head of Global Biometrics hich is based in the US.
- Ensure the study designs are scientifically sound, the efficacy and safety endpoints meets regulatory requirements;
- Provide statistical support to Clinical Development Plan for multiple compounds;
- Participate in pre-IND and NDA/BLA activities;
- Provide statistical input to study protocols, develop statistical analysis plan ;
- Give assistance in writing the clinical study report and publication;
- Monitor and manage internal and CRO project activities;
- Perform efficacy analyses and validate important data derivations with SAS when necessary;
- Develop and implement department standards and actively look to improve the processes;
- PhD or MS in Biostatistics or Statistics;
- At least four to six years' experience for PhD, or eight to twelve years' for MS, as statistician in Pharmaceutical or Biotechnology industries;
- Good knowledge of statistical programming languages (including SAS, R);
- Experience in oncology and/or haematology
- Experience with advanced study design and global regulatory submissions
- Knowledge of SDTM/ ADAM standards.
- Attractive basic salary
- Extra benefit package
- Extremely rapid growing company with a lot of future career opportunities
If this job sounds interesting to you, please apply here or send your CV to me, Sofie Thijs, via the web page of NonStop consulting. You can find me on Linked In as well. If you are not available but you know someone that would be interested, please forward this to them and help out the people in your network!
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