Site Name: USA - Pennsylvania - Philadelphia, USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham
Posted Date: Mar 3 2020
To perform study extraction programming from the Inform data capture system (eCRF) and external vendor data to SDTM domains that are aligned to GSK and regulatory standards. This will include hands on programming utilizing SAS, applying standard templates and providing QC of work to ensure delivering to the agreed specifications and to the GSK and regulatory standards.
• Bachelors Degree or higher in mathematics, statistics, computer science or related discipline.
- Hands on programming knowledge in SAS 9.3/9.4 in Linux and Windows environment.
- 3 to 5 years SDTM and CDISC experience
- 5 years of programming experience
- Expert knowledge with CDISC and SDTM standards
- Ability to understand different EDC data structures like RAVE, InForm etc...
- Experience working in database systems and environments, including Oracle and Unix
- Ability to manage conflicting demands and priorities
- Effective written and verbal communication skills
- Ability to explain complex technical principles to non-technical staff
Responsibilities include, but are not limited to:
- Subject matter expert in SDTM to support project teams and deliverables
- Program extracted data from Inform/RAVE data capture system to SDTM domains that are aligned to GSK and regulatory standards
- Transform and map external vendor data to agreed SDTM format.
- Interpret data specifications and develop code to transform data aligned to these specifications
- Ensures data programming procedures are of the highest quality and are audit ready
- Follow standard operating procedures to ensure high quality and consistency
- Embed efficiencies within programming practices that facilitate re-use
- Ability to QC as validation programmer through double-programming technique.
- Ability to develop complex re-usable SAS macros for data conversion.
- Validate transformed SDTM data against regulatory utilizing industry standard validation programs (i.e. Pinnacle 21)
- Coach and mentor colleagues with advanced programming tasks.
- Provide input to the development of data capture tools for a clinical study
- Ensures data programming procedure are of the highest quality and are audit ready
- Lead role in the management of the data vendor deliverables and performance.
- Subject Matter Expert for the Data Quality Community bringing programming expertise, which would include expert input into to and the development, implementation and communication of programming control documents.
- Oversees CDISC/SDTM conversions with both internal and external partners.
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