RemoteLeads Logo
Sign Up Sign In

Contract Statistical Programmer

2 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
View All Jobs

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

Similar Roles

Teachable

Senior Software Engineer

Teachable 51-250 Internet Software & Services

Teachable is hiring a Senior Software Engineer to help improve software delivery and deployment processes for its creator-education platform.

Brazil Contract Senior Software Engineer
AWS CI/CD Docker Go Kubernetes Microservices Ruby Terraform
1 day, 16 hours ago
Janea Systems

Senior Software Engineer ML - Contractor position

Janea Systems 11-50 Internet Software & Services

Janea Systems (USA) is seeking a Senior ML Engineer contractor to support remote, client-facing consulting engagements that take enterprise ML and LLM systems from prototype to production.

United States Contract Senior Machine Learning Engineer Software Engineer
Apache Airflow AWS Azure CI/CD Dagster Datadog GCP Kubeflow Kubernetes LLM MLOps NLP Prefect Python PyTorch TensorFlow
4 days, 16 hours ago
Affirm

Staff Software Engineer, Backend (Card)

Affirm 1K-5K Diversified Financial Services

Affirm is hiring a lead software engineer to own EU cards engineering, shaping technical strategy and architecture for real-time and post-transaction payment systems across teams in Spain, Poland, and the broader company.

Poland Contract Lead Software Engineer
AWS Kotlin Kubernetes MySQL Python
4 days, 16 hours ago
Highstreet IT

2026-1616 Oracle EBS Technical Consultant

Highstreet IT 51-250 Internet Software & Services

Oracle EBS Technical Consultant at an enterprise-focused organization, responsible for building, customizing, and supporting Oracle E-Business Suite technical solutions and related integrations.

India Contract Senior Database Administrator Software Engineer
Agile REST API Scrum SQL
1 week ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers