Clinical Data Programmer SAS II - CDPSAS
Novotech, a clinical research organization (CRO), is hiring a Clinical Data Programmer II in India to build reports, dashboards and visualizations from clinical trial and operational data for data managers, reviewers and project managers. Day-to-day work centers on extracting/transforming EDC study data and programming outputs with SAS/Python/R/SQL and BI tools like Spotfire, Power BI, Tableau.
- Compensation
- Not disclosed
- Location
- India
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Not specified
- Posted
Skills
Must have
- Graduate degree in computer science, data science, mathematics or life science related field, or similar
- Minimum 2 years of experience in business intelligence, data science, data analysis, 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
- Statistical programming skills in SAS, Python, R, or similar languages
- Knowledge of SQL and Electronic Data Capture (EDC) systems
- Good knowledge of clinical study data structures and schemas of EDC databases
- Expert knowledge in data processing such as extracting, integrating, transforming and presenting data
- Working knowledge of data visualization and analytics tools including Spotfire, Power BI, Tableau, Qlik, or similar
- Experience gathering business and user requirements from multiple stakeholders and clients and advising on appropriate data visualizations
- Awareness of regulatory and compliance issues and application of SOPs and Quality Control to daily activities
- Excellent analytical, communication and problem-solving skills
Nice to have
- 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
Full description
Brief Position Description:
The Clinical Data Programmer SAS II (CDP SAS) 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.
Minimum Qualifications & Experience:
A graduate qualification in computer science, data science, mathematics, life sciences or a related field. A minimum of two years’ relevant experience in statistical programming, business intelligence, data analysis or data science within a pharmaceutical company, CRO or EDC software provider. Practical experience using SAS and/or business intelligence tools (e.g. TIBCO Spotfire, Power BI), to interrogate clinical, laboratory or operational datasets is required. Exposure to additional analytics, RBQM, centralised monitoring or workflow automation platforms is desirable.
Responsibilities:
The Clinical Data Programmer SAS II (CDPSAS) partners with clinical study teams and other stakeholders to define, develop, validate, deploy and maintain fit-for-purpose programming and analytics solutions, including dashboards, graphs, tables, listings and reports.
1. Project/Clinical Studies
- Partner with CDMs, CDRs, PMs and other study stakeholders to define clinical, laboratory, external and operational data requirements and recommend fit-for-purpose dashboards, visualisations, listings and reports.
- Manage assigned programming deliverables from requirements gathering and specification through development, testing, deployment, maintenance and change control in accordance with applicable procedures.
- Extract, integrate, transform and analyse clinical study data from EDC, laboratory, operational and other sources using SAS and relevant technologies.
- Develop validated, reusable programs and analytical outputs that support data inspection, reconciliation, clinical and medical review, operational oversight and timely study decision-making.
- Develop and maintain analytics supporting risk-based quality management and centralised monitoring, including key risk indicators, quality tolerance limits, site performance oversight and identification of meaningful data trends and quality signals.
- Perform quality control, peer review and troubleshooting of programming deliverables, and ensure programs are appropriately validated across development, user acceptance testing and production environments.
- Conduct review sessions, present outputs and analytical findings to study stakeholders, and provide training to support effective use of the solutions.