Vice President, Biostatistics

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $330k - $390k / year

⏰ Full Time

🔴 Lead

👔 Vice President

🦅 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 enterprise-level strategic statistical leadership and oversight across assigned programs and the broader Biostatistics function • Drive cross-functional collaboration, quantitative decision making, and development strategy for programs • Oversee Contract Research Organizations (CROs) • Develop and mentor statisticians and people leaders • Act as Head of Biostatistics when needed • Provide executive-level leadership for strategy covering design, analysis/synthesis, interpretation and reporting, health authority response, publication strategy, and quantitative decision making • Lead senior-level collaborations with clinical, regulatory, and other strategic functions • Provide strategic oversight and guidance for staff and CROs delivering high-quality study deliverables • Lead or sponsor development and review of Policies, SOPs, and controlled documents • Provide senior strategic statistical input in regulatory documents and scientific articles • Lead data generation strategy for podium presentations and payor discussions • Shape team development, succession planning, departmental strategy, and functional strategy • Represent the organization on scientific advances in the field • Perform other duties as assigned

🎯 Requirements

• PhD in Statistics, biostatistics or related fields or Masters with significant 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 • Hands-on familiarity with common and advanced statistical methodology • Strong knowledge of SAS programming concepts and techniques in the pharmaceutical industry • Proficiency in tools such as SAS, EAST, and nQuery • Knowledge/experience of global regulatory requirements in novel endpoints and rare diseases is a plus • Travel less than 5%