Clinical Data Programmer II

Novotech Global•Charleston, SC

About The Position

The Clinical Data Programmer Analyst II (CDPA) is responsible for data analysis and business intelligence activities related to study related clinical and operational data for the purpose of facilitating clinical data inspection and quality control, as well as operational performance control of clinical sites by creating reports, visualisations and dashboards for Clinical Data Managers (CDM), Clinical Data Reviewers (CDR), Project Managers (PM) and other clinical study stakeholders. The Clinical Data Programmer SAS II (CDPSAS) is responsible for assisting clinical study teams and other stakeholders to deliver data visualisations (Graphs/Dashboards) and reports (Tables, Listings) using Business Intelligence/Clinical Data Visualisation tools.

Requirements

Good knowledge of clinical study data structures and schemas of EDC databases.
Expert knowledge in data processing activities such as extracting, integrating, transforming and presenting data.
Statistical programming skills in SAS, Python, R, or similar programming languages.
Knowledge of SQL and Electronic Data Capture (EDC) systems.
Experience with RBQM and centralized monitoring platforms, such as Medidata Clinical Data Studio (CDS) and CluePoints.
Experience with clinical data review, reporting, and workflow automation tools, such as JReview and Power Automate.
Working knowledge of data visualization and analytics tools, including Spotfire, Power BI, Tableau, Qlik, or other similar platforms.
Experience in gathering business and user requirements from multiple stakeholders and clients and provide guidance on the use of appropriate data visualisations.
Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities.
Excellent analytical, communication and problem-solving skills.
Graduate in computer science, data science, mathematics or life science related field, or similar.
A minimum of two years of experience in a role related to business intelligence, data science, data analysis, and clinical data management or clinical data programming in a pharmaceutical company, CRO or EDC software provider.
Familiar with Business Intelligence tools to interrogate clinical and laboratory datasets (e.g. TIBCO Spotfire, Power BI), and/or statistical software.

Responsibilities

Gather clinical and external data reporting and visualisation user requirements from CDMs, CSRs, PMs and other study stakeholders to facilitate data inspection, data reconciliation, and clinical/medical review, and provide guidance on appropriate output formats (dashboards, visualisations, listings, reports).
Gather operational reporting and visualisation requirements from study stakeholders in order to assess the operational performance of clinical sites making use of risk-based approaches (e.g. key risk indicators, quality tolerance limits), and provide guidance on appropriate output formats (dashboards, visualisations, listings, reports).
Document user requirements and undertake programming of the data visualisations (Graphs/Dashboards) and reports (Tables, Listings) using prototyping techniques and ensure the final programs are validated as they move through the development stages (DEV, UAT, PROD), as per applicable procedures.
Educate and train the users of the data visualisations (Graphs/Dashboards) and reports (Tables, Listings) on how to use all the features in the data visualisation software platform in order to inspect and explore the data and make business decisions.
Extract, assess, integrate, transform clinical study data from EDC and other sources during study conduct to provide the data visualisation outputs to the study users, i.e. CDMs, CSRs, PMs and others.
Conduct review sessions with the study team members as required.
Update or create ad hoc data visualisations and reports based on the change-requests from the study stakeholders according to applicable procedures.
Maintain documentation within project files and maintain timesheets.
Participate in Clinical Data Visualisation team and Biometrics department meetings.
Ensure proficiency with Business Intelligence, Clinical Data Visualisation tools and SAS software.
Assess and implement new data analysis, BI and data visualisation processes and technologies.
Assist in mapping existing data visualisation output to re-usable and validated program templates that can be stored in a searchable library.
Ensure compliance with Novotech’s corporate SOPs and applicable regulatory guidelines.
Adhere to SOPs and best practice instructions and templates related to clinical data visualisation.
Assist in the development of SOPS, templates, best practices, process improvement, quality control and governance related to all clinical data visualisation matters.
Good knowledge of clinical study data structures and schemas of EDC databases.
Expert knowledge in data processing activities such as extracting, integrating, transforming and presenting data.
Ensure compliance with Novotech’s corporate SOPs and applicable regulatory guidelines.
Adhere to SOPs and best practice instructions and templates related to clinical data visualisation.
Assist in the development of SOPS, templates, best practices, process improvement, quality control and governance related to all clinical data visualisation matters.