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.
Main Responsibilities, Activities, Duties and Tasks
* Fulfil the role of lead statistical programmer on in-house clinical trial project work as part of the biometrics team.
* Support the data review in clinical studies where programming is outsourced to a contract research organization (CRO) (i.e., TFLs, CDISC data {SDTM and ADaM} and data submission packages {e.g., define.xml, Pinnacle21, Data Reviewer Guides}).
* Development of a new SCE for statistical programming activities.
* Creation/review of standard operating procedures related to programming.
* Establish and develop internal SAS programming macros.
* Establish and develop internal standards for CRFs, SDTM and ADaM data.
* Develop and validate technical programming specifications for analysis datasets using ADaM/ADaM-like standards.
* Review of CSPs, SAPs, TFL Shells, and CSRs.
* Review of database setup documents in clinical study setup (e.g., DM Plans, CRFs, Database Specifications, Edit Check Specifications).
* Provide internal Biometrics trainings to other functions within Blue Earth Diagnostics as required.
* Other duties as determined by business needs.
Education
BSc (Hons) Computer Science or a related field
Professional Experience, Knowledge & Technical Skills
Extensive experience as a statistical programmer in a CRO or in the pharmaceutical/biotechnology industry
In-depth understanding of SAS programming concepts, good programming practices and techniques related to drug development
In-depth understanding of CDISC Standards
In-depth understanding of the drug development process, including experience with regulatory filings
Proficient understanding of DM processes and documentation
Knowledge of Good Clinical Practice (GCP) regulations/requirements
* Oncology and diagnostic imaging experience
* Machine learning and artificial intelligence (AI), i.e., future evolving technologies as and when they become more relevant to the Life Sciences Industry
Soft Skills – Company Values & Behaviours
Ability to work in a high paced team environment, meet deadlines, & prioritize work on multiple projects
Ability to accurately estimate effort required for project related programming activities.
Experience and skills with cross-functional and highly matrixed organizations.
Excellent oral & written communication skills.
Strong coaching, facilitation, and organizational skills