Statistical Programmer Consultant

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $80 - $100 / hour

⏳ Contract/Temporary

🟠 Senior

🔴 Lead

🖥 Software Engineer

👻 Ghost score 10%

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Logo of Kyverna Therapeutics

Kyverna Therapeutics

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Act as the lead programmer for assigned clinical trials and work closely with the study statistician, clinical data management, and other study-team functions. • Lead the strategic design, creation, mapping, and validation of SDTM and ADaM datasets, ensuring data traceability. • Perform statistical analysis and program and validate Tables, Listings, and Figures using SAS for Clinical Study Reports, Development Safety Update Reports, ad-hoc requests, and publications. • Review and ensure the quality of CDISC packages, including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for eCTD submissions. • Perform other duties as assigned.

🎯 Requirements

• Bachelor’s, Master’s in Statistics, Biostatistics, Computer Science, Mathematics, or a highly related Scientific discipline. • 8+ years of statistical programming experience within a bio/pharma company, or clinical research organization (CRO). • Advanced proficiency in SAS, including complicated data steps, Macro language, and commonly used analysis procedures such as PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED. • Comprehensive understanding of CDISC standards and experience generating regulatory package artifacts like define.xml and Reviewer's Guides (cSDRG, ADRG). • Strong communication, analytical, and problem-solving skills, with excellent time management and the ability to independently manage multiple high-priority projects in a fast-paced environment. • Excellent interpersonal skills and the ability to collaborate effectively as part of a cross-functional team. • Demonstrated ability to work independently, communicate proactively, and deliver results effectively in a remote work environment.

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