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A global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality that utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death.
Novocure’s commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications – non-small cell lung cancer, pancreatic cancer, and other types of solid cancers.
We are looking for a principal biostatistician for our global biostatistics and data management team.

As a principal biostatistician, you will lead the statistical aspects of our clinical trials. The role will involve defining and implementing statistical techniques commonly used for oncology clinical trials, working on key department deliverables involving designing and analyzing clinical trials, and leading the statistical aspects for regulatory submissions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Modeling clinical data with Cox Models, Kaplan-Meier Estimates, competing risks
Contribute to study design by incorporating adaptive design, superiority and non-inferiority trials, propensity score matching, and conducting meta-analyses.
Contribute to protocol development in conjunction with clinical development and operations teams and responsible for assessing the feasibility of the study endpoints and developing the Statistical Analysis Plan (SAP)
Report the study results in the Clinical Study Report (CSR)
Oversight of the CRO and validate other vendors’ statistical activities
Provide statistical advice and manage statistical aspects of clinical and preclinical projects
Approve statistical outputs: Table, Listing, and Figures (TLFs) and the analysis datasets produced by the statistical programming team using SAS
Work within a multidisciplinary team and serve as a point of contact between clinical operation, CRO, and SAS programmers within the statistical department
Provide statistical input for the study-related documents: study execution plans (including Data Management Plan), eCRF design and Edit Checks specifications, eCRF completion guidelines and data reconciliation plans
Review SAS coding and specifications
Other responsibilities as assigned