Lead Clinical SAS Programmer
vor 1 Woche
Location:
Root D4, CH, 6039Novocure 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 which 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, ovarian cancer and other types of solid cancers.
To support our team in Root, Switzerland we are looking for aLead Clinical SAS Programmer
In this role you will become a leading element in our Data Management and Biostatistics team, responsible for designing and implementing end-to-end infrastructure for clinical data SAS programming.
From validation programs throughout the steps of the study until final package assembly for regulatory submissions you will implement your deep knowledge of SAS programming skills while also guiding other team members along the way.
Your responsibilities:
- Programming of SAS datasets and development of SAS macros, templates and utilities for data cleaning and reporting.
- Creation of Study Data Tabulation Models (SDTM) and Analysis Data Model (ADaM) datasets
- Definition of statistical data specifications for the respective study datasets.
- Creation of department SOP's related to clinical programming procedures.
- Interfacing with data management and clinical departments to identify, program edit checks as per the defined Data Validation/Data Management Plan and study management repots in SAS.
- Writing of SAS programs with the goal to generate tables, listings and figures (TLFs) and analysis datasets.
- Performing of validations of programmed analysis datasets, tables and listings and figures and participation in preparation of clinical and statistical summary reports.
- Review of CRFs to ensure consistency with protocol and adequacy to collect the data to meet the objectives defined in the statistical section of the protocols and review of CRF annotations and database data specifications.
- Close collaboration with Biostatistic and Data Mangement Team members on clinical projects.
Your profile:
- You bring at least a bachelor's degree in computer science, life sciences, statistics or any other relevant topic. Higher education is beneficial.
- You have experience working in statistical programming in various phases of clinical trials working for either a pharmaceutical company or CRO.
- Extensive experience with SAS/STAT, SAS Macro language SAS/Graph, SAS Output and Deliver System (ODS)
- Experience creating SDTM and ADAM datasets following CDISC standards for regulatory submissions.
- Capabilities in SQL and R programming are beneficial.
- You are familiar with ICH GCP, CFR and other relevant regulations and guidelines.
- Excellent communication skills in English (verbal and written).
- Willingness for occasional travels especially to our RnD facilities in Haifa, Israel.
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