Programming Contractor

🔥 3 hours ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

👻 Ghost score 10%

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Logo of ProKidney Corp.

ProKidney Corp.

51 - 200 employees

Founded 2015

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • 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

• Develop, validate, and maintain SAS programming deliverables supporting clinical study analysis and reporting • Program and validate tables, listings, figures, and derived datasets using SAS • Develop SDTM and ADaM specifications, datasets, and supporting documentation • Prepare and review mapping specifications, annotated case report forms, define, SDRG, ADRG, and other submission files • 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 to stakeholders • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree required 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 • 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 • Ability to work independently and manage multiple priorities in a deadline-driven environment • Phase 3 and regulatory submission experience preferred • Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship

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