Director, Biostatistics, WCH

Biogen•San Francisco, CA

1d•$209,000 - $288,000•Remote

About The Position

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).

Requirements

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 Haves

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

Responsibilities

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

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation