Senior Statistical Programmer

PVR Technologies, Inc   King Of Prussia, PA   Full-time     Information Services / Technology (IT)
Posted on June 5, 2021

Senior Statistical Programmer

Duties: Provide matrix leadership to programming teams, coordinate & team activities. Lead programming tasks, supports clinical development program, compound, or submission; Lead RWD & RWE related activities, enterprise data platform, manage data standardization, computation infrastructure, tool development, & external engagement; Work on Integrated Summaries of Safety (ISS) & Efficacy (ISE) involving pooling of data from 6 to 7 clinical studies; Manage MedDRA, WHO-DRUG, CTC Common Toxicity Criteria, FDA regulations 21 CFR part 11, ICH guidelines & GCP requirements in new drug development & application process. Lead process improvement initiatives, Statistical Programming Plan, SAP, CRFs & Data Management Plan; Perform and manage duties such as data transformation and data manipulation processes & ORACLE database management.

Skills: ISS, ISE, SAP, CRFs & Data Management Plan. Skills: ISS, ISE, SAP, CRFs & Data Management Plan. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US. 

Requirements: Master’s degree in Biotechnology, Statistics with 2 year of experience in a job title with similar duties and skills.