Executive Director, Statistical Programming

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $298k - $340k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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4D Molecular Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏭 Manufacturing

🧬 Biotechnology

Consulting • Manufacturing • Biotechnology

4D Molecular Therapeutics is a clinical stage biopharma company inventing and developing innovative products to unlock the full potential of genetic medicine, aiming to treat both large market and rare diseases. Utilizing its Therapeutic Vector Evolution platform, the company leverages directed evolution to create customized AAV vectors with superior therapeutic profiles. With a diverse pipeline including five product candidates in clinical trials targeting seven patient populations, 4DMT is committed to addressing challenges in genetic medicine and pursuing potential curative therapies while fostering a collaborative and innovative environment.

📋 Description

• Provide strategic and operational statistical programming leadership for assigned indications and development programs • Partner with biostatisticians and cross-functional stakeholders to review statistical analysis plans and develop data and analysis programming specifications • Ensure complete, auditable, inspection-ready programming documentation for clinical-trial analyses and regulatory submissions • Lead development, governance, documentation, and maintenance of reusable programming code, standards, templates, and best practices • Partner with IT and functional leadership to define and maintain statistical computing infrastructure, including the SAS server environment and related tools • Provide senior statistical programming expertise and biometrics leadership on selected projects and cross-functional initiatives • Collaborate on CRF/EDC development and quality data collection for assigned clinical trials • Oversee biometrics vendors and external programming partners, ensuring timely, high-quality deliverables, issue escalation, and accountability • Conduct or coordinate quality review of outsourced statistical deliverables, including in-house double programming or quality control as needed • Lead or contribute to function-level standards, SOPs, work instructions, templates, and continuous improvement initiatives • Monitor industry developments in biostatistics, statistical programming, regulatory expectations, automation, and data standards • Establish programming strategy, resource priorities, quality expectations, and risk mitigation plans, and communicate decisions and escalations to senior stakeholders • Perform other duties as assigned • Work in primarily sedentary conditions with typical office or administrative environmental exposure

🎯 Requirements

• A./B.S. degree in statistics, computer science, or another quantitative science major required • 17+ years of relevant statistical programming, biometrics, or clinical development experience, including significant leadership experience in clinical development and regulatory submissions • Demonstrated experience leading statistical programming strategy and execution for regulatory submissions, including BLA/IND or equivalent global health authority submissions • 8+ years of management experience, including scale-up of an in-house programming team • Expert SAS programming skills, including SAS/BASE, SAS Macros, SAS/STAT, and ODS • Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint • Strong understanding of clinical-trial standards, including CDISC, SDTM, ADaM, CDASH, MedDRA, and WHODrug • Knowledge of applicable GCP, FDA, CHMP, ICH, and HIPAA regulations • Less than 5% travel • Advanced degree preferred, or equivalent experience • Experience in ophthalmology and/or biologic/gene therapy a plus • Proficiency in SAS/SQL, SAS/GRAPH, SAS/ACCESS, R, Excel/PowerPoint Chart features, P21 checks, and experience across clinical phases I–IV are desirable or a plus • Strong organization, prioritization, time management, attention to detail, communication, analytical, strategic, interpersonal, vendor oversight, people leadership, and project management skills • Ability to identify risks and drive decision-making, escalation, and resolution • Sedentary work and repetitive wrist, hand, finger, typing, and speaking activities

🏖️ Benefits

• Equal employment opportunities without regard to protected characteristics • Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities