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ClinChoice

Senior Statistical Programmer/Analyst Consultant – TA, Gene Therapy

ClinChoice

. Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting .

Posted 10/15/2026contractRemote • United StatesSeniorWebsite

About the role

Key responsibilities & impact
  • Lead statistical programming activities for Gene Therapy clinical trials from study start-up through database lock, analysis, and reporting
  • Develop, review, and validate SAS programs for SDTM, ADaM, Tables, Listings, and Figures (TLFs)
  • Collaborate with Biostatisticians to interpret study protocols, Statistical Analysis Plans (SAPs), and programming specifications
  • Develop and validate clinical datasets and statistical outputs for safety and efficacy analyses
  • Support interim and final analyses, database lock activities, and Clinical Study Report preparation
  • Ensure programming deliverables comply with CDISC standards and applicable regulatory requirements
  • Perform independent validation and quality control of datasets, TLFs, and other programming outputs
  • Support regulatory submissions and address programming-related questions from internal and external stakeholders
  • Manage study-level programming timelines, deliverables, and quality expectations
  • Identify and resolve complex programming issues and proactively communicate risks
  • Provide technical guidance and mentorship to other Statistical Programmers
  • Participate in client-facing meetings and collaborate with cross-functional project teams

Requirements

What you’ll need
  • Bachelor's or Master's degree in Statistics, Biostatistics, Mathematics, Computer Science, or a related field
  • Significant experience in clinical trial statistical programming within a pharmaceutical, biotechnology, or CRO environment
  • Hands-on experience supporting Gene Therapy clinical trials is required
  • Strong proficiency in SAS programming
  • Strong knowledge of CDISC standards, including SDTM and ADaM
  • Experience developing and validating clinical trial TLFs
  • Ability to independently lead study-level programming activities
  • Understanding of clinical trial processes, statistical analysis, and regulatory reporting
  • Excellent analytical, communication, and problem-solving skills

Benefits

Comp & perks
  • Professional development and training
  • Supportive culture
  • Close management and training
  • Continuous training
  • Equal opportunity and diversity/inclusivity commitment