Director, Statistical Programming

Director, Statistical Programming

4DMT 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, which substantially reduces the treatment burden associated with current bolus injections. The Company's lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company's second product candidate is 4D-710, which is 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.

The Director of Statistical Programming will focus on applying programming methodology for implementing statistical analyses using SAS for in-house deliverables and performing quality review of outsourced statistical deliverables. They will participate as active members of a cross-functional team to plan, lead and execute the tasks required to support the assigned programs.

Major duties and responsibilities include :

• Provide statistical programming leadership for an assigned indication that may consist of multiple clinical trials
• Work closely with biostatisticians to review the SAP, and responsible in the development of data / analysis program specification based on the SAP
• Maintain complete and auditable programming documentations for analysis of clinical trials
• Contribute to the development, documentation and maintenance of reusable programming code library
• Collaborate with IT to set-up / maintain the statistical computing infrastructure (e.g., SAS server)
• May act as a biostatistician on small-scale projects
• Collaborate with various functions to ensure robust CRF / EDC development, and quality data collection for the assigned clinical trials
• Oversee the biometrics vendors to ensure the prompt and quality statistical deliverables
• Provide quality review of outsourced statistical deliverables (including inhouse double programming to QC as needed) and coordinate the inhouse review comments
• Contribute to the development of functional-level standards, SOPs, and work instructions and templates
• Stay abreast of industry development in biostatistics / statistical programming fields and apply to appropriate systems and processes
• Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

Qualifications :

Travel :

Physical Requirements and Working Conditions :

Base salary compensation range : $228,000 - 256,000. Please note, the base salary compensation range and actual salary offered to the final candidate depends on various factors : candidate's geographical location, relevant work experience, skills, and years of experience.

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws. Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities