8 months ago
This is an opportunity to serve as a cross-functional leader and collaborate closely across Biostatistics, Clinical Data Management, Medical Affairs, Clinical, and Regultaory to support a robust oncology pipeline.
- Create and implement programming plan in accordance with submission standards and clinical protocols
- Develop SAS programs to produce quality and timely deliverables, including SDTM and ADaM datasets, define .xml, and tables
- Conformance check SDTM and ADaM datasets
- Identify and propose solutions for any issues
- Ensure datasets are in compliance with submission standards
- Lead programming team to create submission package
- Manage, oversee, and review all CRO programming activities
- BS in Life Sciences, Statistics, Computer Science, or related field required
- Advanced degree (MS or higher) strongly preferred
- Minimum of 5 years experience in pharmaecutical/biotech drug development
- Demonstrated expertise in CDISC standards, including SDTM and ADaM
My team and I are working on a variety of additional opportunities for a broad portfolio of clients across the US and internationally. If this role isn't for you but you would like to explore your options in the market, I would welcome a confidential conversation at your convenience. Please contact me at (619) 350-6149 or email@example.com.