Contract Statistical Programmer

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🕒 July 24

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Iovance Biotherapeutics, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments.

📋 Description

• Develop, validate, and maintain SAS and/or R programs for the creation of SDTM, ADaM datasets, and TLFs in accordance with CDISC standards. • Support statistical analyses for periodic safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports (CSRs), regulatory submissions, health authority requests and other ad hoc analyses and reporting needs. • Ensure all programming activities comply with FDA 21 CFR Part 11, GxP, and internal SOPs. • Collaborate with biostatisticians, data managers, and clinical teams to define analysis specifications and resolve data issues. • Perform quality control and detailed review of statistical programs and outputs. • Develop and maintain reusable macros, templates, and automation tools to improve programming efficiency. • Contribute to the evaluation and implementation of emerging technologies and modern programming approaches, including AI-based tools and agents, to enhance statistical programming workflows. • Participate in development and review programming data specifications. • Maintain clear, thorough documentation to support audit readiness and regulatory inspection. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

🎯 Requirements

• Master’s degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 5+ years of relevant industry experience; or bachelor’s degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 8+ years of relevant industry experience • Strong proficiency in SAS and/or R for clinical trial data analysis and reporting • Working knowledge of CDISC standards (SDTM, ADaM, Define-XML) and regulatory submission requirements • Experience producing TLFs and SDTM/analysis datasets in a pharmaceutical, biotechnology, or CRO setting • Experience with oncology clinical trials or cell/gene therapy programs • Strong analytical, problem-solving, and communication skills • Familiarity with regulatory guidelines (FDA, ICH) and GxP-compliant programming practices • Excellent attention to detail, problem-solving skills, and the ability to manage multiple priorities independently in a remote environment

🏖️ Benefits

• Iovance Biotherapeutics’ core values • Flexibility to work remotely