Associate Director / Director, Statistical Programming

MeiraGTx Limited; United States; Remote; USD 180.000 - 250.000; Vollzeit

Zusammenfassung

MeiraGTx Limited seeks an Associate Director/Director, Statistical Programming to lead programming for clinical studies and development programs. You will ensure quality, timeliness, traceability, and regulatory readiness of SDTM/ADaM deliverables and define.xml, while managing CROs and cross-functional partners.

The role blends hands-on programming with strategic oversight in a biotech setting, focusing on scalable standards, automation, and compliant reporting for regulatory submissions.

Qualifikationen

• PhD/MD or advanced degree in a quantitative field is preferred.
• 10+ years in statistical programming within pharma/biotech/CRO.
• Strong SAS programming expertise for clinical data analysis and reporting.
• Deep knowledge of CDISC SDTM/ADaM and define.xml.
• Experience leading programs and vendor management for regulatory submissions.
• Familiarity with GCP/ICH guidance and electronic submission expectations.
• Experience with Pinnacle 21 and risk-based validation.

Aufgaben

• Provide technical and operational leadership for statistical programming across studies.
• Oversee CROs/contractors and ensure regulatory readiness of deliverables.
• Guide SDTM/ADaM datasets, tables, listings, figures, and define.xml.
• Lead integrated and exploratory analyses and regulatory responses.
• Shape scalable, automation-focused programming standards.

Kenntnisse

Statistical programming

SAS programming

SDTM/ADaM

Regulatory submissions

Vendor oversight

Leadership

GCP/ICH

Ausbildung

Statistics/biostatistics degree

Tools

Pinnacle 21

R

Python

Jobbeschreibung

Associate Director / Director, Statistical Programming

Remote

Your mission

The Associate Director / Director, Statistical Programming will provide technical and operational leadership for statistical programming across clinical studies and development programs. The role is accountable for the quality, accuracy, timeliness, traceability, and regulatory readiness of programming deliverables, including SDTM and ADaM datasets, tables, listings, figures, define.xml, reviewer guides, integrated analyses, exploratory analyses, and responses to regulatory questions.

This is a hands‑on leadership role suited to a growing biotechnology environment. The successful candidate will combine strong programming expertise with strategic oversight of CROs and contractors, effective cross‑functional partnership, and a practical focus on scalable standards, automation, and fit‑for‑purpose processes.

Job Description

Required Qualifications

• 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, including 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.
• Demonstrated 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 with resolving validation findings in a documented, risk‑based manner.
• Proven 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 the ability to influence effectively in a cross‑functional matrix.

Preferred Qualifications

• 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.

Core Competencies

• Clinical programming and regulatory submission leadership.
• Quality, compliance, and inspection readiness.
• Strategic planning and risk management.
• CRO and vendor oversight.
• Cross‑functional influence and communication.
• Technical problem‑solving and innovation.

Working Conditions

• Work arrangement: Remote, US eastern standard time zone preferred.
• Travel: up to 10-15%, based on business needs.
• The role may require flexibility during database locks, major submission milestones, or urgent regulatory responses.

About us

MeiraGTx is a clinical‑stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state‑of‑the‑art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000‑square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.