Associate Director of Biostatistics
Founded in 2011, this 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 methods by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled them 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 across the globe.
The Company has recently successfully completed an initial public offering (IPO) and its commercial organization is building the pre-launch market activities. With office in Europe and the US, their global reach is second to none
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.
Job Responsibilities
- At project level, ensures the study designs are solid, 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 publication and report
- 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
Requirements
- PhD or MS in Biostatistics/ Statistics or other relevant areas;
- 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
