Clinical Programmer IV

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 2022 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 of programming activities

Mandatory Requirements

·Bachelor’s degree in Statistics, Mathematics, or Computer Science or a related field

·5+ 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.

·Strong MS Office skills (Word, Excel, PowerPoint), and skills in generating graphs and figures.

·Proficiency in a LINUX environment

Additional Notes

·NDA submission experience is a plus

·Master’s degree is a plus (Biostatistics, Pharmacology, Biology, Biomedical Sciences)

·Must be willing to support a global organization

·Experience with SAS Grid Manager a plus

Terms & Start

·12-month contract

·Remote/home-based

·Employer contributed health benefits (medical, dental, vision)