Contract Statistical Programmer

iovancebiotherapeutics; Deutschland; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Iovance Biotherapeutics seeks a Contract Statistical Programmer to develop, validate, and maintain statistical programming deliverables for clinical studies and regulatory submissions. You will work with statisticians, data management, and cross-functional teams to ensure high-quality datasets, tables, listings, and figures in a GxP environment.

The ideal candidate has strong programming and statistics foundations and thrives in a collaborative biotech setting, contributing to regulatory filings

Qualifikationen

• Master's degree with 5+ years of industry experience or Bachelor's with 8+ years.
• Strong proficiency in SAS and/or R for clinical data analysis.
• Experience with CDISC SDTM/ADaM and regulatory submissions.
• Experience in oncology or cell/gene therapy programs preferred.

Aufgaben

• Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs.
• Support statistical analyses for periodic safety reports, publications, and submissions.
• Ensure all programming activities comply with FDA 21 CFR Part 11, GxP, and SOPs.
• Collaborate with biostatisticians and data managers to define analysis specs and resolve data issues.
• Perform quality control and detailed review of statistical programs and outputs.
• Develop reusable macros, templates, and automation tools to improve efficiency.
• Contribute to evaluation of AI-based tools to enhance workflows.
• Maintain documentation to support audit readiness and regulatory inspection.

Kenntnisse

Analytical thinking

Problem-solving

Communication skills

Ausbildung

Master's degree in mathematics, statistics, computer science, biostatistics, data science or related quantitative field

Bachelor's degree in mathematics, statistics, computer science, biostatistics, data science or related quantitative field

Tools

SAS

R

CDISC SDTM/ADaM

Jobbeschreibung

Iovance Biotherapeutics 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 human immune system to recognize and attack diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

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-quality and timely delivery of datasets, tables, listings, and figures in a GxP-compliant environment. The ideal candidate combines strong programming expertise with a solid foundation in statistics or quantitative sciences and thrives in a collaborative, fast-paced biotech setting.

Essential Functions and Responsibilities

• 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.
• 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 clear, thorough documentation to support audit readiness and regulatory inspection.
• Must adhere to Iovance Biotherapeutics' core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Master's degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 5+ years of relevant industry experience; or bachelor's degree in mathematics, statistics, computer science, biostatistics, data science or a related quantitative field with 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 (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 clinical trials 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

• 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 standar