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Contract Statistical Programmer

1 month, 3 weeks ago
United States
Contract
Senior
Software Engineer
Software Development
Machine Learning R Statistics
Apply Now
Iovance Biotherapeutics

Iovance Biotherapeutics

Iovance Biotherapeutics is a biopharmaceutical company pioneering TIL therapy to treat cancer by utilizing the patient's immune system to target cancer cells.

Pharmaceuticals
251-1K
Founded 2007
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Description

  • Develop, validate, and maintain SAS and/or R programs for SDTM, ADaM datasets, and TLFs in accordance with CDISC standards.
  • Support statistical analyses for safety reports, publications, conference presentations, IDMC/DSMB reviews, CSRs, regulatory submissions, and ad hoc requests.
  • 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 efficiency.
  • Contribute to evaluating and implementing emerging technologies, including AI-based tools and agents, for programming workflows.
  • Participate in the development and review of programming data specifications.
  • Maintain clear documentation to support audit readiness and regulatory inspection.
  • Perform miscellaneous duties as assigned.

Requirements

  • 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 one of these fields 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.
  • Ability to manage multiple priorities independently in a remote environment.
  • 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 is a significant plus.
  • Experience supporting regulatory submissions such as NDA, BLA, or MAA is preferred.
  • Familiarity with eCTD and health authority interactions is preferred.

Benefits

  • Remote work environment.
  • Annual base salary of $70–$80 USD per hour.
  • Equal-opportunity employer committed to diversity and inclusion.
  • Accommodation available for applicants who need assistance to apply.

Interested in this position?

Apply directly on the company website

Apply Now

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