Contract Statistical Programmer

Iovance Biotherapeutics

5h•Remote

About The Position

Iovance Biotherapeutics 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. The role works closely with statisticians, data management, and other cross-functional teams to deliver high-quality, timely datasets, tables, listings, and figures in a GxP-compliant environment. The ideal candidate has strong programming expertise and a foundation in statistics or quantitative sciences, and can work collaboratively in a fast-paced biotech setting. The role involves programming for clinical trial datasets and reporting, supporting safety and regulatory analyses, contributing to programming specifications and quality control, and maintaining documentation for audit readiness. It also includes evaluating and implementing emerging technologies, including AI-based tools and agents, to improve statistical programming workflows. The position operates in a professional office or remote work environment and requires routine use of standard office equipment and technology. Remote employees are expected to maintain a safe workspace free from recognized hazards.

Requirements

Master’s degree in mathematics, statistics, computer science, biostatistics, data science, or a related quantitative field with at least 5 years of relevant industry experience; or bachelor’s degree in one of these fields with at least 8 years of relevant industry experience.
Strong proficiency in SAS and/or R for clinical trial data analysis and reporting.
Working knowledge of CDISC standards, including SDTM, ADaM, and Define-XML, and regulatory submission requirements.
Experience producing TLFs and SDTM/analysis datasets in a pharmaceutical, biotechnology, or CRO setting.
Experience with oncology clinical trials or cell/gene therapy programs.
Strong analytical, problem-solving, and communication skills.
Familiarity with FDA and ICH regulatory guidelines and GxP-compliant programming practices.
Excellent attention to detail and ability to manage multiple priorities independently in a remote environment.
Ability to remain stationary for extended periods, move about 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.
Ability to perform repetitive motion involving wrists, hands, and/or fingers and communicate effectively to exchange information.
Ability to engage in analytical, conceptual, and problem-solving activities in a dynamic business environment.

Nice To Haves

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.
Experience supporting regulatory submissions such as NDA, BLA, MAA, or equivalent.
Familiarity with electronic submission standards (eCTD) and health authority interactions.

Responsibilities

Develop, validate, and maintain SAS and/or R programs to create SDTM and ADaM datasets and tables, listings, and figures (TLFs) in accordance with CDISC standards.
Support statistical analyses and reporting for periodic safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports, regulatory submissions, health authority requests, and ad hoc needs.
Ensure 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.
Contribute to the evaluation and implementation of emerging technologies and modern programming approaches, including AI-based tools and agents.
Participate in development and review of programming data specifications.
Maintain clear, thorough documentation to support audit readiness and regulatory inspection.
Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
Perform miscellaneous duties as assigned.