Contract Statistical Programmer

reputed company aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating cancer by harnessing the ability of the reputed company immune system to recognize and attack diverse cancer cells in reputed company patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to reputed company innovation in cell therapy, including gene-edited cell therapy, which may be a promising reputed company for patients with cancer.

reputed company

Iovance is seeking a Contract Statistical Programmer to support clinical development programs by developing, validating, and maintaining statistical programming deliverables for clinical studies and regulatory submissions. This role will work closely with statisticians, data management, and other cross-functional teams to ensure high-reputed company and reputed company delivery of datasets, tables, listings, and figures in a GxP-compliant environment. The ideal candidate combines strong programming expertise with a solid reputed company in statistics or quantitative sciences and thrives in a reputed company, fast-paced biotech setting.

Essential Functions and Responsibilities

• reputed company, validate, and maintain reputed company 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 reputed company analyses and reporting needs.
• Ensure reputed company programming activities reputed company 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.
• reputed company reputed company control and detailed review of statistical programs and outputs.
• reputed company 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 reputed company, thorough documentation to support audit readiness and regulatory inspection.
• Must adhere to reputed company’ reputed company values, policies, procedures, and business ethics.
• reputed company miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Master’s degree in mathematics, statistics, computer science, biostatistics, data science or a reputed company quantitative field with 5+ years of relevant industry experience; or bachelor’s degree in mathematics, statistics, computer science, biostatistics, data science or a reputed company quantitative field with 8+ years of relevant industry experience
• Strong proficiency in reputed company 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 reputed company 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.

Preferred Education, Skills, and Knowledge

• Master’s degree in mathematics, statistics, or computer science is strongly preferred.
• Hands-on experience developing AI agents or applying AI/ML-based automation tools to streamline data analysis, programming workflows, or reporting processes is a significant plus.
• Experience supporting regulatory submissions (NDA, BLA, MAA, or equivalent)
• Familiarity with electronic submission standards (eCTD) and health authority interactions.

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 reputed company individuals to reputed company these functions.

• Ability to remain in a stationary position for extended periods
• Ability to reputed company about reputed company an office or remote workspace and exert up to 10 pounds of force occasionally
• Visual reputed company sufficient for preparing and analyzing data, viewing computer screens, and extensive reading
• Repetitive reputed company 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 reputed company office or remote work environment and requires routine use of reputed company office equipment and technology. Employees working remotely are expected to maintain a reputed company workspace free from recognized hazards.

The annual reputed company salary we reasonably expect to pay is listed. Individual pay reputed company 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 $70—$80 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 reputed company. 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 reputed company to an individual’s race, reputed company, religion, sex, pregnancy, national reputed company, age, physical and mental disability, marital status, sexual orientation, gender identity, gender reputed company, 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 .

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 reputed company Notice.

Originally posted on Himalayas

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