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.

Demonstrated ability and experience in leading collaborative efforts to obtain and analyze complex data.

Proficiency in SAS; familiarity with R is highly desirable.

Preferred Education, Skills, and Knowledge

Working knowledge of FDA, EMA, and ICH statistical guidance; experience supporting regulatory submissions including NDA, BLA, or MAA preferred.

Physical Demands and Activities Required

The physical demands described here represent those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be provided to enable individuals to perform these functions.

Ability to remain in a stationary position for extended periods

Ability to move about within an office or remote workspace and exert up to 10 pounds of force occasionally

Visual acuity sufficient for preparing and analyzing data, viewing computer screens, and extensive reading

Repetitive motion involving wrists, hands, and/or fingers

Ability to communicate effectively to exchange information

Cognitive: Ability to engage in analytical, conceptual, and problem‑solving activities in a dynamic business environment

Work Environment

This role operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Employees working remotely are expected to maintain a safe workspace free from recognized hazards.

#LI-remote

The annual base salary we reasonably expect to pay is listed. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of the role, job duties/requirements, and relevant education, experience and skills.

Pay Transparency

$145,000 — $175,000 USD

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact [email protected] .

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice .