Senior Data Management Programmer/SDTM Specialist, Life Sciences
Oracle
Oracle Life Sciences is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Oracle Life Sciences, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research. Oracle Life Sciences is passionate about our people, our business, and our clients and is proud to foster a culture that contributes to the health and well-being of humankind.
As a global leader we’re looking for a Senior Data Management Programmer to drive success as part of our international Data Management team. Join us and create the future.
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Are you an experienced Senior Data Management Programmer who enjoys working with large data sets? If you have experience working with Statistical Analysis Systems (SAS) in clinical trials and non-interventional studies (NIS), this is an incredible opportunity to excel in an exciting engaging environment!
Career Level - IC3
What you will do
As a Senior Data Management Programmer you will lead programming tasks for clinical trials and NIS, owning and handling specifications, databases and datasets, tools, interfaces, validation, documentation, and oversight in line with SOPs, sponsor standards, CDISC, and regulatory requirements.
Responsibilities include:
- Lead the creation of SAS annotations/specifications according to sponsor/CDISC standards; develop and validate SDTM and sponsor-specific SAS datasets.
- Build and maintain programs, macros, and tools; standardize data management programming procedures.
- Program and validate status reports and listings for internal and external use.
- Coordinate processing and administration of external data (e.g., lab and 3rd party data).
- Design and test study-specific validation, including eCRF/UAT; collaborate with Statistics and Data Management.
- Contribute in the creation of the Data Management Plan, Data Validation Plan, and Data Management Report specifications; maintain complete study documentation and QC; track programming budget and timelines within projects.
- Work on multiple project requests simultaneously.
Required Experience
- Bachelor’s degree or equivalent relevant experience
- Minimum 5 years of experience with SAS programming with international clinical trials and/or NIS, within a CRO environment preferred
- Advanced knowledge of CDISC standards
- Knowledge of SQL and R
- Fluent in English
What we will offer you
- A competitive salary with exciting benefits
- Learning and development opportunities to advance your career
- An Employee Assistance Program to support your well-being
- Flexible and hybrid working so you can do your best work
- Employee resource groups that champion our diverse communities
- Core benefits such as life insurance, and access to retirement planning
- An inclusive culture that celebrates what makes you unique