Director/Sr. Director, Biostatistical Consulting

🕒 vor 2 Monaten

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Allucent

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

Biotechnology • Pharmaceuticals • Science

Allucent ist ein führender Partner für kleine und mittelgroße Biotech-Unternehmen und bietet innovative Lösungen für regulatorische und klinische Entwicklungen. Mit über 30 Jahren Erfahrung spezialisiert sich Allucent auf therapeutische Fachkenntnisse, klinische Pharmakologie, regulatorische Strategien, Arzneimittelsicherheit und Pharmakovigilanz-Prozesse, die notwendig sind, um neue Therapien auf den Markt zu bringen. Ihre umfassenden Dienstleistungen decken Herausforderungen von der frühen Arzneimittelentdeckung über klinische Prüfungen bis hin zur Überwachung nach der Markteinführung ab und unterstützen verschiedene therapeutische Bereiche wie Onkologie, Infektionskrankheiten, Neurologie, Autoimmunerkrankungen und seltene Krankheiten. Allucents Engagement für die Förderung bahnbrechender Wissenschaft hilft Biotech-Unternehmen, die Komplexitäten der Arzneimittelentwicklung effizient und effektiv zu bewältigen.

Beschreibung

• **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

🎯 Anforderungen

• **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.

🏖️ Vorteile

• **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