Contract Statistical Programmer

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 regulatory guidelines (FDA, ICH) and GxP-compliant programming practices.

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.

$70

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$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 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

careers@iovance.com

Develop, validate, and maintain SAS 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 ad hoc analyses and reporting needs.

Ensure all programming activities comply 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 to improve programming efficiency.

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