Consultant, SAS Clinical Programmer, Pharmaceutical
Summary
Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Clinical Programmer.
In this role, you will be responsible for assigned statistical programming activities on a collaboration and license agreement for Europe, China, and other territories.
This SAS programmer will support an ongoing and planned clinical trial analysis, reporting, and MAA submission. The successful candidate will be well-versed in SAS programming, knowledgeable in CDISC data standards, and someone who enjoys collaborating with multiple departments.
Duties / Expectations
- Independently develop / validate programs that generate SDTM and analysis datasets based on ADaM specifications
- Prepare / QC ADaM datasets documentation : Define.xml, Reviewer’s Guide, and analysis metadata report
- Independently develop / validate programs that generate tables and listings specified in the protocol or the Statistical Analysis Plan (SAP)
- Perform quality control on final reports
- Provide QC and validation reports
- Support development of technical programming specifications for ADaM standards
- Communicate with programming and statistics leads, data managers, and other team members
- Provide project progress updates on programming activities
Mandatory Requirements
- Bachelor’s degree in Statistics, Mathematics, or Computer Science or a related field
- 8+ years of SAS programming and application development experience in Biotechnology / Pharmaceutical / CRO
- Industry experience as a clinical trial SAS programmer; SAS experience in drug development in CRO or pharma / biotech company
- Knowledgeable in Base SAS, SAS Macros, SAS / STAT, SAS / Graph, SAS / SQL, and SAS / ODS
- Familiar with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines.
- Proficiency in a LINUX environment
- Experience with all clinical phases I, II, III, and IV of trials
- NDA submission experience
Additional Notes
- Master’s degree is a plus
- Must be willing to support a global organization
- Experience / Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide and SAS Studio is a plus
Terms & Start
- 12-month contract
- Remote / home-based
- Employer contributed health benefits (medical, dental, vision)
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