We're 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 hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which we have proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled us to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers with significant unmet need. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to pivotal Phase 2 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.
Position Overview
This position is responsible for statistical activities in support of clinical trials outside of the US.
This position reports to Head of Global Biometrics based in New Jersey.
Requirements
- 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);
- Solid oncology and/or hematology experience
- Experience with advanced study design or at least one NDA/BLA eCTDs or other global regulatory submissions
- Experience as an independent lead statistician with responsibility for multiple studies or projects
- Excellent interpersonal, leadership and communication skills and ability to work independently and collaboratively;
- Knowledge of SDTM/ ADAM
Job Responsibilities
- At project level, ensures 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
- At study level, provide statistical input to study protocols, develop statistical analysis plan
- Assist in writing relevant sections of the clinical study report and publication
- Monitor internal and CRO project activities including timelines, deliverables and resources
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Develop and implement department standards and lead process improvements
The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. There are operations in Lausanne Switzerland (Head office and Clinical), London UK (R&D), New Jersey US (Clinical and Commercial) and San Francisco US (CMC manufacturing)
