Contract Statistical Programmer

Job not on LinkedIn

🕒 July 24

🇺🇸 United States – Remote

💵 $70 - $80 / year

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🖥 Software Engineer

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Logo of Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc.

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 SDTM, ADaM datasets, and tables, listings, and figures in accordance with CDISC standards • Support statistical analyses for safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports, regulatory submissions, health authority requests, and ad hoc analyses • Ensure programming complies 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 • Evaluate and implement emerging technologies, including AI-based tools and agents, to enhance statistical programming workflows • Participate in developing and reviewing programming data specifications • Maintain documentation for audit readiness and regulatory inspection • 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 these fields 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, including SDTM, ADaM, and Define-XML • Knowledge of 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 • Familiarity with FDA and ICH regulatory guidelines and GxP-compliant programming practices • Strong analytical, problem-solving, and communication skills • Ability to manage multiple priorities independently in a remote environment • Ability to remain stationary for extended periods • Ability to move within an office or remote workspace and exert up to 10 pounds of force occasionally • Visual acuity for preparing and analyzing data, viewing computer screens, and extensive reading • Repetitive motion involving wrists, hands, and/or fingers • Ability to communicate effectively • Ability to engage in analytical, conceptual, and problem-solving activities • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics

🏖️ Benefits

• Reasonable accommodation may be provided to enable individuals to perform required functions • Professional office or remote work environment • Equal-opportunity and diverse, inclusive work environment

Apply Now

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