commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe, and Israel.
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 Clinical Programmer for our global Biostatistics team.
As a Clinical Programmer, you will play a key role in the design and implementation of the complete infrastructure for clinical data programming.
This includes creating SAS derivations, analysis, and validation programs throughout the various stages of the study, until the final package assembly for regulatory submissions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Program SAS datasets, develop SAS macros, templates, and utilities for data cleaning and reporting
Create, review, and validate Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets
Create, review, and validate SAS programs to generate tables, listings, and figures (TLFs) and ad-hoc analysis under the guidance of the project statistician and the lead clinical SAS programmer
Define and review statistical data specifications for the study datasets
Participate in the preparation of clinical and statistical summary reports
Participate in automatizing standard programs and processes
Interface with data management to identify and program edit checks per the Data Validation Plan/Data Management Plan and study management reports using SAS
B.Sc. or higher degree in computer science, life sciences, pharmacy, statistics, or equivalent relevant degree a must
Knowledge:
Working experience with SAS/STAT an advantage
Background in data modeling, classification, clustering and regression analysis an advantage
Experience in the clinical programming field, creating/reviewing SDTM, and ADaM datasets following CDISC standards for regulatory submissions an advantage
SQL, Python, or R programming capabilities or similar – an advantage
Fluent in English (verbal and written) and excellent communication skills, ability to work both independently and collaboratively a must
Responsible, detail-oriented, and creative with excellent organizational skills a must
Demonstrate strong critical thinking and problem-solving skills, and a can-do attitude a must