Director/Sr. Director, Biostatistical Consulting

🕒 Março 31

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Allucent

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

A Allucent é um parceiro de referência para empresas de biotech de pequeno e médio porte, oferecendo soluções inovadoras em assuntos regulatórios e desenvolvimento clínico. Com mais de 30 anos de experiência, a Allucent é especializada em expertise terapêutica, farmacologia clínica, estratégia regulatória, segurança de medicamentos e nos processos de farmacovigilância necessários para levar novas terapias ao mercado. Seus serviços abrangentes abordam desafios desde a descoberta de fármacos em fases iniciais até os ensaios clínicos e a vigilância pós-comercialização, apoiando diversas áreas terapêuticas, como oncologia, doenças infecciosas, neurologia, doenças autoimunes e doenças raras. O compromisso da Allucent em fomentar ciência de ponta ajuda as empresas de biotech a navegar pelas complexidades do desenvolvimento de medicamentos de forma eficiente e eficaz.

Descrição

• **About the role:** • As an expert in biostatistics consulting and leading a team, you will: • - **Provide expert statistical consulting** to sponsors across clinical program development, protocol design, sample size calculations, endpoint selection, and regulatory interactions to support clinical trial strategy and decision-making • - **Lead and manage complex biostatistics projects** by overseeing statistical analysis plans, ensuring quality and integrity of statistical documents and outputs, and serving as the lead unblinded statistician for high-complexity studies • - **Manage team and resources** including supervising direct reports, allocating appropriate staffing to projects, leading project budgets, and ensuring adequate resourcing for biostatistics and statistical programming activities • - **Drive business development and client relationships** by representing Allucent in proposal presentations, establishing and maintaining strong client relationships, identifying key accounts, and contributing to marketing activities through publications and presentations • - **Ensure regulatory compliance and cross-functional collaboration** by maintaining adherence to SOPs and regulatory guidelines, interfacing with regulatory bodies on statistical submissions, and coordinating with clinical operations, medical writing, and other functional areas to deliver high-quality, timely study deliverables

🎯 Requisitos

• **To be successful you will possess:** • - **Graduate Degree.** Master's degree (or local equivalent, or higher) in a relevant discipline such as statistics, mathematics, life science, epidemiology, or healthcare. • - **Extensive Experience.** Minimum 15 years of relevant work experience, including at least 10 years in drug development and/or clinical research; preference for experience in Oncology, Neuroscience, or Infectious Disease therapeutic areas. • - **Regulatory and Compliance Knowledge.** Thorough knowledge of GxP, strong familiarity with regulations including GDPR/HIPAA, CFR/CTR/CTD, and applicable local requirements. • - **Technical and Statistical Proficiency.** Strong skills in SAS and/or other statistical programming languages; proficiency with sample size software packages, computer systems/applications (e.g., Word, Excel, PowerPoint), and operating systems. • - **Soft Skills and Leadership. **Strong critical thinking, analytic, written/verbal communication (including English), presentation, networking, organizational, negotiating, and financial skills; demonstrated leadership, problem-solving, strategic thinking, conflict resolution, collaboration, client-focus, and ability to manage multiple tasks in a fast-paced environment. • - **Personal Attributes.** Excellent attention to detail, commitment to quality, individual initiative, administrative excellence, and ability to simplify complex issues, establish relationships, and maintain a reputation for sustained performance.

🏖️ Benefícios

• **Benefits of working at Allucent include:** • - Comprehensive benefits package per location • - Competitive salaries per location • - Departmental Study/Training Budget for furthering professional development • - Flexible Working hours (within reason) • - Opportunity for remote/hybrid* working depending on location • - Leadership and mentoring opportunities • - Participation in our Buddy Program as a new or existing employee • - Internal growth opportunities and career progression • - Financially rewarding internal employee referral program