Statistical Programmer Contractor

ProKidneyRemote

Remote Contract

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Experience Level

Mid to Senior

Qualifications

Qualifications: Bachelor’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field is required; a Master’s degree is preferred. A minimum of 10 years of relevant statistical programming experience in the pharmaceutical, biotechnology, or CRO industry. Experience with Phase 3 and regulatory submissions is highly preferred. Proficient in SAS programming, with demonstrated experience in developing SDTM, ADaM datasets, and creating tables, listings, and figures. Strong understanding of clinical trial processes, regulatory requirements, and programming documentation standards. Exceptional attention to detail coupled with strong analytical, problem-solving, and communication skills.

About the job

ProKidney is hiring a Statistical Programmer Contractor for a remote contract position. The main focus is supporting clinical study analysis and reporting through SAS programming. This contractor will work closely with Biostatistics and project teams to ensure high-quality, compliant deliverables such as datasets, tables, listings, and figures. Meeting regulatory standards and project timelines is essential in this role.

Main responsibilities

Develop and validate tables, listings, figures, and derived datasets using SAS.
Create SDTM and ADaM datasets, along with all required supporting documentation.
Prepare and review mapping specifications and annotated case report forms (CRFs).
Perform quality control and validation checks on programming outputs.
Work with study team members to identify, investigate, and resolve data discrepancies and output issues.
Review study documents and provide feedback to improve programming quality, efficiency, and consistency.
Maintain thorough, accurate, and audit-ready programming documentation.
Communicate project status, risks, issues, and any potential timeline changes to stakeholders.

Collaboration and standards

This role involves close collaboration with Biostatistics and other cross-functional colleagues. All work must align with standard operating procedures (SOPs), regulatory requirements, and CDISC standards.

About ProKidney

ProKidney is dedicated to advancing kidney health through innovative solutions and is committed to creating an inclusive work environment that values diversity and individual contributions. We believe in fostering a culture of collaboration, excellence, and respect, where every employee's voice is heard and valued.

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