Associate Director, Biostatistics

🕒 Julho 23

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $193.000 - $212.000 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Diretor

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4D Molecular Therapeutics

SiteLinkedInTodas as Vagas

51 - 200 funcionários

💼 Consultoria

🏭 Manufatura

🧬 Biotecnologia

Consulting • Manufacturing • Biotechnology

A 4DMT é uma empresa biofarmacêutica em fase clínica que inventa e desenvolve produtos inovadores para desbloquear todo o potencial da medicina genética no tratamento de doenças de grande mercado e doenças raras. Nossa plataforma de descoberta de vetores, a Therapeutic Vector Evolution, aproveita o poder da evolução dirigida, uma tecnologia vencedora do Prêmio Nobel, com aproximadamente um bilhão de sequências derivadas de capsídeos sintéticos de AAV para inventar vetores personalizados e evoluídos com perfis terapêuticos aprimorados em comparação com vetores do tipo selvagem. Nosso motor de design, desenvolvimento e manufatura de produtos nos capacita a criar com eficiência nosso valioso e diversificado pipeline de produtos. Esta combinação de inovação ousada e execução implacável dá à 4DMT a capacidade de revolucionar os medicamentos genéticos e buscar terapias potencialmente curativas. Construímos um portfólio profundo de candidatos a produtos de medicina genética, com cinco candidatos a produtos em ensaios clínicos para sete populações de pacientes.

Descrição

• Provide statistical expertise and collaborate with various functions on study design/planning, protocol development, statistical methodology/analysis • Responsible for the development of statistical analysis plan (SAP), TFL shells and other analysis specifications on assigned studies • Responsible for the development of randomization schema on assigned randomized studies • Perform data analysis and/or collaborate with statistical programming (inhouse or vendor) to ensure quality analysis conducted per the SAP and specifications • Responsible for the development of statistical reports summarizing the data analysis results • Ensure adequate interpretation of data/analysis results and 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 the assigned clinical trials • Provide quality review of outsourced statistical deliverables (including in-house double programming to QC as needed) and coordinate the in-house review comments • 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

🎯 Requisitos

• 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/FDACHMP//ICH/HIPPA regulations • Displays excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a fast-paced environment with shifting priorities and/or conflicting deadlines • Excellent written and verbal communication skills and strong team player with demonstrated track record of success in cross-functional team environment.

🏖️ Benefícios

• 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