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 Consultant Application Programmer

Details
Country: USA
Location: Pennsylvania-Philadelphia Horsham, PA 19044
Total applied: 14
Consultant Application Programmer

A leading pharma in the Horsham area is in need of a Consultant Application Programmer. The Consultant Application Programmer is responsible for leading the group that provides systems support and software/program development to aid the conduct and analysis of Phase II - IV clinical trials and regulatory submissions.Travel RequirementsApproximately 10%, local and international Essential Duties & Responsibilities 1. Maintain SAS Programming environment in a validated state ensuring conformity with relevant regulatory requirements  2. Ensure that other software installations used by the BDM Department are properly validated  3. Serve as the lead SAS administrator supervising access, data transfers, and settings  4. Designs statistical programming practices including necessary SOPs  5. Writes and validates standard macros.  Maintains global macro library.  6. Develop, maintain, and implement data standards for clinical projects  7. Ensures compliance with applicable standards and practices of statistical work performed  8. Provide training for statistical programmers  9. Responsible for ensuring quality, implementation and timeliness of standards and deliverables  10. Evaluate and recommend new system processes and/or technologies which offer opportunities to improve business processes  11. Develop, mentor, and supervise application programming staff  12. Ensure that application programming resources are well planned for based on staff availability, priorities and timelines  13. Obtain user requirements and ensure customer support for new applications  14. Other duties as assigned or as business needs require  Primary Outcomes1. SAS programming environment that facilitates the rapid high quality analyses of clinical trials and preparation of regulatory submission 2. Effective management and prioritization of application programming projects and resourcesPosition Requirements Education Required: Bachelor's degree in statistics, computer science, or other relevant field Education Preferred Master of Science or PhD in statistics, computer science, or other relevant field Experience Required: " SAS Programming including global SAS macro development " Production of Tables, Figures, and Listings for clinical trials " Preparation of datasets and programs for regulatory submission " Minimum of 8 years of pharmaceutical  or related industry experience Experience Preferred: " Installation and Development of SAS programming environment     Functional Knowledge: " Software Development Life Cycle " Computer system validation " CDISC " 21CFR11 requirementsMinimum Requirements:Consultant Application Programmer - Bachelor's degree in statistics, computer science, or other relevant field; Master of Science or PhD in statistics, computer science, or other relevant field (preferred); SAS experience including clinical trials; Minimum of 8 years of pharmaceutical  or related industry experience; CDISC; SAS Programming including global SAS macro developmentMUST HAVES: SAS experience including clinical trials customer focus and good communication abilities SDLC and validation knowledge CDISC and eCTD experience Education:Bachelor's Degree Reference Code:3021519 Email:Apply by Email

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