Job Description
Job purpose
Reporting to the Director of Biometrics, the Principal Statistical Programmer will primarily oversee the development and execution of all programming activities at Blue Earth Diagnostics. They must possess extensive experience and proven skills in the use of Statistical Analysis System (SAS) within a clinical Programming environment and have a complete knowledge and understanding of programming processes and procedures.
The Principal Statistical Programmer will be involved in reviewing Clinical Data Interchange Standards Consortium (CDISC) submissions for Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) packages provided by third party vendors and the generation of quality check (QC) datasets, tables, listings and figures (TFLs) for internal evaluation, discussion and publications. They will also lead the development of a new Statistical Computing Environment (SCE) for programming activities and establish and develop internal standards for case report forms (CRFs), SDTM and ADaM data. This role will also include the development of current in-house macros and establishing new in-house macros for the SCE. Additionally, this role will involve the review of clinical study protocols (CSPs), statistical analysis plans (SAPs), clinical study reports (CSRs) and data management (DM) documentation for Blue Earth Diagnostics sponsored or managed clinical trials, where required. <...