paul dolhai

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

Helped train junior colleagues

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

Run routine QC programs 

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

University of Teesside 

Masters degree in Computer Aided Graphical Technology Applications

McMaster University 

Undergraduate degree in Honors, Computer Science