Senior Manager, Biostatistics

About   Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics , Inc.  is the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) cell therapies for patients with solid tumors. Amtagvi® (lifileucel) is the first FDA-approved, one-time treatment for previously treated advanced melanoma, now approved in three global markets and available at more than 95 authorized treatment centers. The  Iovance TIL platform  spans registrational trials and next-generation programs in additional solid tumors, including gene-edited and IL-12 tethered TIL therapies, next-generation IL-2, and precision immuno-oncology approaches. As the first and only company to take TIL therapy from concept to a broadly accessible commercial treatment, Iovance operates as an end-to-end cell therapy company, anchored by fully owned, centralized U.S.-based manufacturing that is scaled to serve thousands of cancer patients worldwide each year. For more information, please visit  www.iovance.com .

Amtagvi® and its accompanying design marks, Proleukin ® , Iovance ® , and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.

Information on Iovance’s broad, industry-leading patent portfolio is available on the Intellectual Property page on  www.iovance.com .

Overview

The Senior Manager, Biostatistics provides statistical leadership for complex clinical studies in cell therapy oncology programs. This role is responsible for study design, statistical analysis, interpretation of results, and communication of statistical findings. Working independently with minimal supervision, the Senior Manager, Biostatistics serves as the lead statistician for assigned studies, collaborates with cross-functional project teams, and oversees statistical activities performed by contract research organizations (CROs) to ensure high-quality and timely deliverables.

Essential Functions and Responsibilities

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.

Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

Ph.D in Statistics, Biostatistics, or related field with 3–5 years of relevant industry experience in healthcare, or M.S. degree with 6–8 years of relevant industry experience in healthcare.

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.