Vice President, Biostatistics

About the role

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 incumbent provides enterprise-level strategic statistical leadership and oversight across all statistical aspects of assigned programs and the broader Biostatistics function; drives cross-functional collaboration, quantitative decision making, and development strategy for program(s); oversees the performance of Contract Research Organizations (CROs); develops and mentors statisticians and people leaders, and acts as Head of Biostatistics when needed.

Responsibilities

• Provides executive-level leadership and accountability for strategy (design, analysis/synthesis, interpretation and reporting, health authority response, publication strategy, and quantitative decision making) in the global development program
• Leads senior-level collaborations with clinical, regulatory and other strategic functions to drive quantitative decision making and enable successful impact on robust drug development plans
• Provides strategic oversight and guidance to staff members within 4DMT and in CROs in completing high quality study deliverables according to agreed timelines following quality standards
• Leads and/or sponsors the development and review of Policies, SOPs and other controlled documents for process improvement, inspection readiness, and operational efficiency
• Provides senior strategic statistical input in regulatory documents and scientific articles
• Leads data generation strategy for podium presentations and payor discussions
• Plays a critical role in shaping team development, succession planning, and contributing to departmental and functional strategy
• Stays abreast of, contributes to, and represents the organization on scientific advances in the field
• Other duties as assigned

Requirements

• Education: PhD in Statistics, biostatistics or related fields or Masters with significant experience
• Experience: 14+ years of pharmaceutical industry experience with a PhD, or 15+ years with an MS
• Hands-on experience working with CDISC standards and programming based on raw datasets, SDTM, and ADaM datasets
• 10+ years of management experience, including leadership of senior technical talent and people managers

Skills

• Hands-on familiarity with common and advanced statistical methodology
• Strong knowledge of SAS programming concepts and techniques in the pharmaceutical; proficiency in tools such as SAS, EAST, and nQuery
• Knowledge/experience of global regulatory requirements in novel endpoints and rare diseases is a plus

Pay

Base salary compensation range: $330,000 - $390,000