Director/Sr. Director, Biostatistical Consulting

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Director/Sr. Director, Biostatistical Consulting (D/SrDBiosC) to join our A-team (office-based*/remote). As a D/SrDBiosC at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department.

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

This role is open to considering candidates from United States or Canada.

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.