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MeiraGTx

Associate Director – Director, Statistical Programming

MeiraGTx

. Provide technical and operational leadership for statistical programming across clinical studies and development programs .

Posted 10/27/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in statistical programming and regulatory submissions within the biotechnology and pharmaceutical industries, with a strong focus on SAS programming, CDISC standards, and clinical trial methodologies. Proven ability to lead cross-functional teams, manage vendor relationships, and ensure compliance and quality in programming deliverables.

Highest-signal resume keywords
Advanced SAS Programming SkillsCDISC Standards KnowledgeStatistical Programming ExperienceRegulatory Submission ExperienceClinical Drug-Development Process Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
SAS/BASESAS MacroSAS SQLODSStatistical ProgrammingClinical Data AnalysisProgramming StandardsData Validation ToolsAutomationRisk Management
Soft Skills
Excellent Communication SkillsAttention to DetailInfluencing SkillsSound JudgmentAbility to Manage Multiple Priorities
Tools & Technologies
Pinnacle 21XMLGitAI-Assisted Programming ToolsCollaborative Programming Environments
Industry Keywords
BiotechnologyPharmaceuticalCROClinical TrialsGCPICH GuidanceNDABLAMAARare Disease

Tech Stack

Tools & technologies
CloudGoogle Cloud PlatformPythonSQL

About the role

Key responsibilities & impact
  • Provide technical and operational leadership for statistical programming across clinical studies and development programs
  • Ensure the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables
  • Lead delivery of SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory questions
  • Provide hands-on leadership in a growing biotechnology environment
  • Provide strategic oversight of CROs and contractors
  • Partner effectively with cross-functional teams
  • Develop scalable standards, automation, and fit-for-purpose processes
  • Lead clinical programming and regulatory submission activities
  • Support quality, compliance, and inspection readiness
  • Manage strategic planning and risk management
  • Oversee CROs and vendors
  • Influence cross-functional stakeholders and solve technical problems
  • Travel up to 10–15% based on business needs
  • Provide flexibility during database locks, major submission milestones, or urgent regulatory responses

Requirements

What you’ll need
  • Bachelor’s or advanced degree in Statistics, Biostatistics, Mathematics, Computer Science, Data Science, Life Sciences, or a related quantitative discipline
  • At least 10 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry
  • Demonstrated study or program leadership, BLA/NDA/MAA submission experience, vendor oversight, and functional or people leadership
  • Advanced SAS programming skills, including SAS/BASE, SAS Macro, SAS SQL, ODS, and programming for clinical data analysis and reporting
  • Advanced knowledge of CDISC standards, including SDTM, ADaM, controlled terminology, define.xml, and associated implementation guidance
  • Experience producing and overseeing programming deliverables for clinical study reports and regulatory submissions
  • Working knowledge of the clinical drug-development process, clinical trial methodology, statistical concepts, GCP, ICH guidance, and electronic submission expectations
  • Experience with data and submission validation tools such as Pinnacle 21 and resolving validation findings in a documented, risk-based manner
  • Ability to manage multiple priorities, anticipate risks, negotiate realistic timelines, and deliver high-quality work in a fast-paced environment
  • Excellent written and verbal communication skills, sound judgment, attention to detail, and ability to influence effectively in a cross-functional matrix
  • Hands-on experience with global regulatory submissions, including NDA, BLA, MAA, or equivalent submissions, integrated summaries, information requests, inspections, and post-submission analyses
  • Experience in rare disease, gene therapy, ophthalmology, or another complex clinical-development setting
  • Experience with R and relevant clinical-development ecosystems; familiarity with Python, XML, Git, or metadata-driven reporting is an advantage
  • Experience building or governing reusable programming infrastructure, macro libraries, automated QC frameworks, and reproducible reporting workflows
  • Experience authoring or implementing SOPs, work instructions, programming standards, and vendor governance processes
  • Familiarity with validated cloud or collaborative programming environments and responsible use of AI-assisted programming tools
  • Preferred US Eastern Standard Time zone availability

Benefits

Comp & perks
  • Remote work arrangement
  • Travel up to 10–15% based on business needs
  • Flexibility during database locks, major submission milestones, or urgent regulatory responses