Clinical Data Programmer III SAS
Location
India | India
Job description
JOB DESCRIPTION
Minimum Qualifications & Experience:
- Graduate in computer science, data science, mathematics or life science related field, or similar.
- A minimum of 4 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.
- Good knowledge of clinical study data structures and schemas of EDC databases.
- Good knowledge in data processing activities such as extracting, integrating, transforming and presenting data.
- Statistical programming skills in SAS, Python, R or similar.
- Knowledge of SQL and EDC systems.
- Familiar with TIBCO Spotfire, Power BI, Tableau, Cliq or other data review and visualization tool.
- Experience in gathering business and user requirements from multiple stakeholders and clients and provide guidance on the use of appropriate data visualizations.
- Awareness of regulatory and compliance issues and understanding of application of SOPs and Quality Control to daily activities.
Responsibilities:
The Clinical Data Programmer SAS III 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.
1. Project/Clinical Studies
- Work under supervision as Clinical Data Programmer SAS gathering clinical and external data reporting and visualization user requirements from CDMs, CSRs, PMs and other study stakeholders to facilitate data inspection, data reconciliation, and clinical review, and provide guidance on appropriate output formats (dashboards, visualisations, listings, reports).
- Work under supervision as Clinical Data Programmer SAS gathering operational reporting and visualization 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 in consultation with Senior Clinical Data Programmer SAS based on the change-requests from the study stakeholders according to applicable procedures.
- Maintain documentation within project files and maintain timesheets.
2. Clinical Data Visualisation Team
- Participate in Clinical Data Visualisation team and Biometrics department meetings.
3. Software Tools
- Develop proficiency with Business Intelligence, Clinical Data Visualisation tools and SAS software.
4. Clinical Data Visualisation Processes and SOPs
- 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.
ABOUT THE TEAM
Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services.
It has accumulated experience in over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,750 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.
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