Director, Statistics

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 Director, Biostatics who will be responsible for the decision-making regarding any statistical effects and lead a department of biostatisticians.

This full-time position is located in Israel and reported to the Vice President, Biostatistics & Data Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversee statistical leadership in the ongoing clinical studies and for the development of new studies
• Serves as a cross-functional expert across projects and teams, in particular: overseeing protocol development in conjunction with clinical development and operation teams, development of the Statistical Analysis Plan, and reporting study results in the Clinical Study Reports (CSRs). In addition to providing input to IDE and regulatory submissions.
• Led the department’s biostatistics professional aspects, in alliance with the statistical programming and data management aspects.
• Support interactions with global health authorities, as well as with partner contract research organizations.
• Serves as the department SME for internal and external audits
• Ensure quality and timeliness of statistical deliverables
• Responsible for the attestations of data integrity of clinical trials and accuracy of all statistical analyses across all studies.
• Accountable for the accuracy of statistical proposals that are part of materials for health authority meetings
• Contributes to external engagement with consultants, advisory boards, and DMCB
• Provide consultations to Business Development, Medical Affairs, clinical operation, QA, regulatory department, Health economics and outcomes research (HEOR), pre-clinical Research, and other department in the organization as needed.
• Resource and support analytical activities that are included in plans for scientific publications with the publication and medical affairs teams.
• Continues to resource the team with ongoing assessment of capability needs
• Mentors and develops members of the department
• Establishes best practices, identifies the need, and drives the creation of functional standard operating procedure

QUALIFICATIONS/KNOWLEDGE:

• Qualifications:
• PhD or Master’s degree in computational biology/ Biostatistics

• Knowledge:
• At least 7 years experience in the medical device or pharmaceutical industry
• At least 5 years of managerial experience, including hiring and building a team
• Experience in analyzing randomized clinical trials using SAS including superiority and non-inferiority analyses, CPHMs, sample size assessments, and clinical trial design
• Experience in writing the statistical sections of clinical trial reports
• Experience in writing statistical analysis plans
• Excellent written and spoken English
• Excellent computer skills using: SAS, Python, Office