Director, Biostatistics, WCH

Overview

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.

What you'll do

• 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

What you'll need

• 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

Nice to have

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

Details

• Job level: Management
• Ideally based in the Bay Area (San Francisco, CA); remote candidates considered with the right experience and qualifications
• Base compensation range: $209,000.00-$287,750.00