Senior Manager, Biostatistics

🕒 July 24

🇺🇸 United States – Remote

💵 $145k - $175k / year

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 1%

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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

• Serves as lead statistician for one or more clinical studies and may support program-level statistical strategy. • Leads statistical activities for assigned studies and collaborates with statistical programmers and CRO partners to ensure timely delivery of high-quality statistical outputs. • Authors and reviews statistical sections of study protocols, statistical analysis plans, clinical study reports, regulatory submission documents, and publications including abstracts and posters. • Maintains current knowledge of statistical methodologies, regulatory guidance, and industry best practices relevant to oncology drug development. • May contribute statistical expertise to due diligence activities and cross-functional evaluations when needed. • Creates networks with external statistical and programming collaborators and influences internal decisions to ensure quality of study designs and analyses, appropriateness of inferences and conclusions, and alignment with corporate strategic interests. • Contributes to process improvements, standards development, and statistical best practices within the Biostatistics function. • Works effectively within cross-functional teams to address study-level operational and scientific challenges. • Contributes to knowledge sharing within the department. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

🎯 Requirements

• D. in Statistics, Biostatistics, or related field with 3–5 years of relevant industry experience, or M.S. degree with 6–8 years of relevant industry experience. • Strong experience supporting oncology clinical development programs, including design and analysis of early- and late-phase clinical trials. • Sound knowledge of theoretical and applied statistics, including survival analysis methods, analyses on patient-reported outcome, and health economics. • Effective decision-maker who considers cross-functional and global perspectives, and applies knowledge, detailed analysis, seasoned experience, and sound judgment in making decisions that may involve limited or ambiguous information. • Strong verbal, written, and presentation skills. • Demonstrated ability and experience in leading collaborative efforts to obtain and analyze complex data. • Proficiency in SAS; familiarity with R is highly desirable.