Senior Statistical SAS Programmer
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10+ Years working with Pfizer through Eliassen Group
Worked on submissions for Celebrex, Lyrica, Comirnaty, Xeljanz
Create submission-ready standard data presentations and data sets using standard coding and following OPD processes including SDLC
Understand CDISC SDTM model and Pinnacle21 for validation.
Experience creating SDTM and ADaM compliant datasets.
Experience using CDARS to create tables
Provided programming support for risk and management plans, product defense, rapid responses, and queries from FDA, EMEA and global health authorities.
QC and reviewed data/documents from Eisai for Fragmin studies, summarized the findings, and provided suggestions to Pfizer PoC
Oversaw vendor mapping work for 220 Celebrex studies
Experience working with several Pfizer PoCs
Conduct interim analysis, QC, eSub work, as required
Understand and plan work to delivery timelines including allowing time for internal FSP QC, as appropriate
Work with supervisor to balance conflicting priorities
Understand timelines for and milestones affecting their work and alert supervisor to potential slippage
Ensure training done before embarking on a task
Alert supervisor and PoC where skills or knowledge are not adequate for the task set – seek help
Develop appropriate QC programs as defined at kick-off or by PoC
Follow escalation process and neither suppress nor over- escalate issues
Contribute to close–out evaluations and any discussion
Ensure compliance with Eliassen and industry quality standards, guidelines and procedures
Suggest improvements to standard work processes e.g., suggests new software applications to improve work efficiency/quality
Masters degree in Computer Aided Graphical Technology Applications
Undergraduate degree in Honors, Computer Science
