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.

While this position is ideally based in the Bay Area (San Francisco, CA), we are open to considering remote candidates with the right experience and qualifications.

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

Who You Are:

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.

Required Skills:

• 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

Preferred Skills:

• 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

Additional Information

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Originally posted on Himalayas