Manager, Statistical Programming - Starszy Programista
Core
Design, develop, and implement technical solutions for integrating, analyzing, and reporting clinical data to support regulatory approval and market acceptance of pharmaceutical products.
Role type
Manager, Statistical Programming
Builds
Derived analysis datasets, tables, listings, figures, and regulatory submissions (e-submissions)
Domain
Pharmaceutical clinical development / Biostatistics
Required skills
SAS programming, R programming, CDISC standards (SDTM, ADaM), relational databases, XML, Pinnacle 21, statistical analysis plan review, regulatory standards compliance
Preferred skills
Drug development process knowledge, clinical trial methodology, Linux operating system
Technologies
SAS, R, XML, Pinnacle 21, eDC, SDTM, ADaM
Responsibilities
Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Provide comprehensive programming support for project teams including development of programming strategies and standards; Support electronic submission preparation and review; Review key planning documents to ensure alignment with development team objectives; Interact with vendors regarding project standards and specifications; Ensure quality of deliverables by applying standards and complying with regulatory requirements; Identify opportunities for increased efficiency within the team and with vendors; Lead and perform programming assignments across multiple projects with minimal supervision.
Seniority
Manager, hands-on IC with leadership responsibilities