Associate Director – Director, Statistical Programming

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🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

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MeiraGTx

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

MeiraGTx is a vertically integrated, clinical-stage genetic medicine company focused on developing gene therapies for various diseases, including rare and neurodegenerative diseases. The company has advanced capabilities in viral vector design and optimization, and operates two GMP viral vector production facilities along with its own Quality Control hub. MeiraGTx harnesses innovative technologies like a riboswitch gene regulation platform to precisely control gene expression, aiming to enhance therapeutic delivery for metabolic peptides and further extend genetic medicine applications beyond ocular conditions to address significant unmet needs in various disease areas.

📋 Description

• 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

• 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

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