Principle Biostatistician

Novocure is 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 o ncology 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 by Cox Models, Kaplan-Mier Estimates, competing risks
• Contribute to study design by incorporating adaptive design, superiority, non-inferiority, propensity matching control study and conducting meta-analysis.
• Contribute to protocol development in conjugation with clinical development and operation 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 programmer within the statistical department
• Provide statistical input to the study-related documents: study execution plans (including Data Management Plan), eCRF design and Edit Checks specifications, eCRF completion guidelines, data reconciliation plans
• Review SAS coding and specifications
• Other responsibilities as assigned
  
  

• Qualifications:
  
  

• Knowledge:
• At least 5 years of experience leading statistical aspects in late-phase clinical trials, and oncology studies would be an advantage
• Excellent knowledge of common statistical techniques used in oncology clinical trials, with experience writing SAP and the statistical sections of the CSR
• Previous experience with FDA and/or EMEA submissions
• Excellent proficiency in programming with SAS and/or R
• Knowledge of ICH GCP, CFR, CDISC, and other relevant regulations and guidelines
• Fluent in English (verbal and written) and excellent communication skills
  
  

• Ability to work both independently and collaboratively
• Responsibility, detail-oriented, and creative with excellent organizational skills
• strong critical thinking and problem-solving skills