Contract Statistical Programmer

This is a fully remote position, open to applicants in United States.

📋 Description

• Design, validate, and maintain SAS and/or R programs for generating SDTM, ADaM datasets, and TLFs in line with CDISC standards.

• Assist in statistical analyses for routine safety reports, publications, conference presentations, IDMC/DSMB reviews, clinical study reports (CSRs), regulatory submissions, health authority inquiries, and various ad hoc analyses and reporting requirements.

• Ensure all programming tasks adhere to FDA 21 CFR Part 11, GxP, and internal SOPs.

• Work collaboratively with biostatisticians, data managers, and clinical teams to establish analysis specifications and address data-related issues.

• Conduct quality control and comprehensive reviews of statistical programs and their outputs.

• Create and sustain reusable macros, templates, and automation tools to enhance programming efficiency.

• Contribute to the assessment and adoption of new technologies and innovative programming techniques, including AI-based tools and agents, to improve statistical programming processes.

• Engage in the development and evaluation of programming data specifications.

• Maintain detailed and clear documentation to ensure audit readiness and compliance with regulatory inspections.

• Comply with Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform additional duties as assigned.

⛳️ Requirements

• Master’s degree in mathematics, statistics, computer science, biostatistics, data science, or a related quantitative discipline with over 5 years of relevant industry experience; or a bachelor’s degree in mathematics, statistics, computer science, biostatistics, data science, or a related quantitative field with more than 8 years of relevant industry experience.

• Strong expertise in SAS and/or R for clinical trial data analysis and reporting.

• Familiarity with CDISC standards (SDTM, ADaM, Define-XML) and requirements for regulatory submissions.

• Proven experience in producing TLFs and SDTM/analysis datasets within a pharmaceutical, biotechnology, or CRO environment.

• Background in oncology clinical trials or cell/gene therapy programs.

• Excellent analytical, problem-solving, and communication abilities.

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

• Exceptional attention to detail, problem-solving skills, and the capacity to manage multiple priorities independently in a remote setting.

🏝️ Benefits

• Iovance Biotherapeutics’ core values.

• Flexibility to work remotely.