Director, Biostatistics, WCH

About This Role:

As Director of Biostatistics, West Coast Hub (WCH), you will provide statistical leadership and accountability for all biostatistics activities and deliverables for one or more late-stage nephrology clinical development projects. Acting as indication Biostatistics Lead, your role is crucial in the clinical development and evidence generation strategy and execution, providing direction, oversight and/or direct contributions as appropriate on clinical development plans, protocols and analysis, clinical study reports and regulatory submission materials, and ensures the adherence to regulatory guidelines and scientific rigor.

The Director will coach and supervise statisticians working on the projects, build and maintain strong collaboration with key stakeholders from different disciplines across the organization, and represent Biostatistics on cross-functional teams, in meetings with governance committee, regulatory agencies, advisory boards as appropriate. You will provide mentorship to biostatisticians in the department, and drive innovation and take initiatives for process improvement to facilitate consistent statistical approaches and enhancement of technical capabilities of the department.

This position is ideally based in the Bay Area (San Francisco, CA).

• Develop and direct overall statistical activities for the assigned projects, ensuring high-quality and timely deliverables
• Provide guidance and support for all biostatisticians on the projects through direct supervision, coaching and staff development
• Represent biostatistics on project, study teams and/or internal governance meetings; provide guidance, oversight or direct input into strategy, planning and contents of clinical development plan as well as key components of regulatory submissions and evidence generation
• Provide guidance and direct input in addressing statistical issues in regulatory, legal, or other challenges, and represent the company in regulatory meetings, scientific conferences, or meetings with KOLs
• Lead or participate in initiatives to identify opportunities for clinical development innovation and process improvement, and develop and implement solutions
• Provide broader mentoring and leadership to ensure that the organizational missions and goals are achieved

You are a strategic leader with a deep understanding of statistical principles, clinical trial methodologies and drug development expertise. Your ability to develop innovative solutions and navigate complex regulatory environments sets you apart. You thrive in collaborative settings and have a knack for fostering an inclusive and productive team culture. Your strong communication skills enable you to articulate complex concepts in an accessible way, and you are adept at managing multiple projects and priorities.

Your leadership inspires those around you, and you are committed to excellence and driving success in a fast-paced environment.

• PhD in Biostatistics/Statistics or equivalent
• 8+ years relevant work experience in the pharmaceutical/biotech industry
• Broad and thorough understanding of statistical principles and clinical trial methodology; able to practice and implement them
• Ability to develop innovative/creative statistical/technical solutions to complex problems
• Statistical project leadership experience in late-stage clinical development strategy and execution
• Knowledge and experienced in meeting regulatory guidance, both FDA and international regulatory agencies
• Knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
• Strong verbal and written communication skills
• Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflicts resolutions, and effective partnership

• Past regulatory experiences, including interactions with FDA/EMA/PMDA and BLA/NDA/MAA submission experiences
• Experiences in nephrology or immunology a plus
• People manager with track record of staff development

Management

The base compensation range for this role is: $-$ Base salary offered is determined through an analytical…