we are 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.
our company's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
We are looking for Biostatistics for our Biostatistics team.
As a biostatistician, you will contribute to the statistical aspects of our clinical trials.
The role will involve the usage and implementation of statistical techniques commonly used for Oncology clinical trials.
In addition, the role will include clinical SAS programming for data verification.
This is a full time, Hybrid position as part of our team in Isarel.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Contribute to protocol development in conjugation with clinical development and operation teams and responsible to assess the feasibility of the study endpoints and develop 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
Assist to provide statistical advice and advice on 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.
our company's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
We are looking for Biostatistics for our Biostatistics team.
As a biostatistician, you will contribute to the statistical aspects of our clinical trials.
The role will involve the usage and implementation of statistical techniques commonly used for Oncology clinical trials.
In addition, the role will include clinical SAS programming for data verification.
This is a full time, Hybrid position as part of our team in Isarel.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Contribute to protocol development in conjugation with clinical development and operation teams and responsible to assess the feasibility of the study endpoints and develop 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
Assist to provide statistical advice and advice on 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.
Requirements:
Qualifications:
M.Sc. degree in Statistics/Biostatistics, with at least 3 years of experience working in the area of clinical trials
Knowledge:
You demonstrate basic knowledge of common statistical techniques used in clinical trials
You demonstrate basic knowledge of programming with SAS and/or R
Familiar with ICH GCP, CFR, CDISC, and other relevant regulations and guidelines
Previous experience working with EDC systems
You are fluent in English (verbal and written) and have excellent communication skills, and present the ability to work both independently and collaboratively
You are responsible, detail-oriented, and creative with excellent organizational skills
You demonstrate strong critical thinking and problem-solving skills.
Qualifications:
M.Sc. degree in Statistics/Biostatistics, with at least 3 years of experience working in the area of clinical trials
Knowledge:
You demonstrate basic knowledge of common statistical techniques used in clinical trials
You demonstrate basic knowledge of programming with SAS and/or R
Familiar with ICH GCP, CFR, CDISC, and other relevant regulations and guidelines
Previous experience working with EDC systems
You are fluent in English (verbal and written) and have excellent communication skills, and present the ability to work both independently and collaboratively
You are responsible, detail-oriented, and creative with excellent organizational skills
You demonstrate strong critical thinking and problem-solving skills.
This position is open to all candidates.
