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ProKidney Corp. · 10 hours ago

Programming Contractor

United States

Contract

Remote

Senior Level, Lead/Staff

10+ years exp

ProKidney is a company focused on advancing kidney health, and they are seeking a Programming Contractor to develop programming code using SAS for various statistical outputs. The role involves ensuring quality standards are met, performing validation programming, and maintaining project documentation.

Health CareTherapeutics

No H1B

Responsibilities

Uses SAS to develop programming code to generate summary tables, data listings, graphs, and derived datasets, SDTM and ADaM, as specified in the statistical analysis plan and programming specifications

Creates SDTM and ADaM mapping specifications and, if required, annotation of case report forms (CRFs) to CDISC standards

Works to ensure that outputs meet quality standards and project requirements

Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings

Keeps project team members informed of programming progress and issues requiring their attention

Follows applicable SOPs, WIs, and relevant regulatory guidelines

Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness

Adapts to timeline or priority changes

Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities

Performs other tasks as assigned

Qualification

SASSDTMADaMPharma experienceBiotech experienceCRO experienceMaster's degreeTeam player

Required

10+ years' experience in Pharma, Biotech, or CRO

Strong team player

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

Preferred

Preference for Phase 3 and BLA/NDA submission experience

Master's degree preferred (in Statistics, Computer Science, or a related science discipline)

Company

ProKidney Corp.

ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.

Founded in 2015

Salem, Oregon, USA

51-200 employees