Job Description:
• *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
Requirements:
• *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.
Benefits:
• *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