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:

• Qualifications:

Ph.D./M.Sc. degree in Statistics/Biostatistics

• 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

OTHERS:

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

ABOUT NOVOCURE:

Our vision

Patient-forward: aspiring to make a difference in cancer.

Our patient-forward mission

Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.

Our patient-forward values

– innovation

– focus

– drive

– courage

– trust

– empathy