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Statistical Programmer Contractor

ProKidneyRemote
Remote Contract

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Experience Level

Mid to Senior

Qualifications

A Bachelor’s degree is required; a Master’s degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field is preferred. At least 10 years of relevant statistical programming experience in the pharmaceutical, biotechnology, or CRO sectors. Experience with Phase 3 studies and regulatory submissions is highly desirable. Proficient in SAS programming, with a strong background in developing SDTM, ADaM, tables, listings, and figures. Comprehensive knowledge of clinical trial processes, regulatory standards, and programming documentation requirements. Exceptional attention to detail, coupled with strong analytical, problem-solving, and communication abilities.

About the job

ProKidney is hiring a Statistical Programmer Contractor to support clinical study analysis and reporting. This remote contract position centers on developing, validating, and maintaining SAS programming deliverables. The contractor will work with Biostatistics and cross-functional teams to produce compliant datasets, tables, listings, and figures. Meeting project timelines, following SOPs, and adhering to regulatory guidelines and CDISC standards are key expectations.

Main responsibilities

  • Program and validate tables, listings, figures, and derived datasets using SAS.
  • Create SDTM and ADaM datasets along with supporting documentation.
  • Prepare and review mapping specifications and annotated case report forms (CRFs).
  • Perform quality control and validation for all programming deliverables.
  • Work with study team members to identify and resolve data or output discrepancies.
  • Review study documentation and provide feedback to improve programming quality and consistency.
  • Maintain thorough, accurate, and audit-ready programming documentation.
  • Communicate project status, risks, issues, and timeline impacts to stakeholders.

Requirements

  • Bachelor’s degree required; Master’s in Statistics, Biostatistics, Mathematics, Computer Science, or a related field preferred.
  • At least 10 years of statistical programming experience in pharmaceutical, biotechnology, or CRO settings.
  • Experience with Phase 3 studies and regulatory submissions is highly valued.
  • Advanced SAS programming skills, with experience in SDTM, ADaM, and generating tables, listings, and figures.
  • Strong understanding of clinical trial processes, regulatory requirements, and programming documentation standards.
  • Attention to detail, analytical thinking, and effective communication skills.

About ProKidney

ProKidney is dedicated to enhancing the lives of patients with kidney diseases. We are committed to innovation and excellence in clinical research, striving to deliver high-quality solutions that meet the needs of our stakeholders. As an employer, we are proud to provide equal opportunities for all and create an inclusive work environment.

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