Associate Director, Biostatistics

Overview

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DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection.

The Company’s lead indication for 4D-150 is wet age-related macular degeneration (in Phase 3 development), and the second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis
• Develop statistical analysis plans (SAP), analysis shells and other analysis specifications for assigned studies
• Develop randomization schemas for assigned randomized studies
• Perform data analysis and/or collaborate with statistical programming (in-house or vendor) to ensure quality analysis conducted per the SAP and specifications
• Develop statistical reports summarizing data analysis results
• Interpret data/analysis results and ensure consistency/accuracy of data presentation for study reports and publications
• Collaborate with various functions to ensure robust CRF/EDC development and quality data collection for assigned clinical trials
• Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate in-house review comments
• Stay abreast of industry developments in biostatistics/statistical programming and apply to appropriate systems and processes
• Other duties as assigned by management

• Advanced degree (M.A./M.S. or PhD) preferred, or equivalent experience

• A./M.S. with 7+ years, or PhD with 4+ years in biotech/pharmaceutical industry
• Experience in ophthalmology and/or biologic/gene therapy a plus
• Experience with all clinical phases (I, II, III, and IV) is desirable

• Good understanding of standards specific to clinical trials such as CDISC, SDTM, and ADaM, MedDRA, WHODRUG
• Knowledge of applicable GCP/ICH/HIPAA regulations
• Excellent organization and time management skills, attention to detail, and ability to multi-task in a fast-paced environment
• Excellent written and verbal communication skills and ability to work well in cross-functional teams

Travel: