Statistical Programmer

🕒 April 29

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ProKidney Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

🧬 Biotechnology

⚕️ Healthcare Insurance

Biotechnology • Healthcare Insurance

ProKidney Corp. is a late clinical-stage biotechnology company focused on pioneering cell therapy as a treatment for Chronic Kidney Disease (CKD). Their innovative approach aims to transform the therapeutic options available for advanced CKD by preserving kidney function, potentially delaying or eliminating the need for dialysis. With a focus on an area of high unmet medical need, ProKidney's cell therapy candidate, rilparencel, is at the forefront of clinical studies to provide alternative solutions for patients with limited treatment options. The company is committed to advancing its pipeline through clinical and regulatory developments and actively participates in healthcare conferences to bring attention to its groundbreaking work in CKD treatment.

📋 Description

• Program and validate tables, listings, figures, and derived datasets using SAS. • Develop SDTM and ADaM datasets and supporting documentation. • Prepare and review mapping specifications and annotated case report forms (CRFs). • Perform quality control and validation activities for programming deliverables. • Collaborate with study team members to identify, investigate, and resolve data and output issues. • Review study documents and provide input to improve programming quality, efficiency, and consistency. • Maintain complete, accurate, and audit-/inspection-ready programming documentation. • Communicate project status, risks, issues, and timeline impacts clearly to stakeholders.

🎯 Requirements

• Bachelor’s degree required; Master’s degree preferred in Statistics, Biostatistics, Mathematics, Computer Science, or a related field. • Minimum of 10 years of relevant statistical programming experience within the pharmaceutical, biotechnology, or CRO industry. • Phase 3 and regulatory submission experience preferred. • Strong SAS programming skills, with experience developing SDTM, ADaM, tables, listings, and figures. • Strong knowledge of clinical trial processes, regulatory requirements, and programming documentation. • High attention to detail, with strong analytical, problem-solving, and communication skills.

🏖️ Benefits

• ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. • Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.