Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.
About This Role: As the Head of Biostatistics, West Coast Hub (WCH), you will lead the Biostatistics function for our portfolio of immune-mediated diseases, covering both early and late clinical development stages. This Senior Director level role will be instrumental in developing and overseeing strategic directions to ensure the scientific integrity and operational efficiency of biostatistical elements across multiple indications, driving innovations for Biogen WCH assets and development programs. This role is crucial for the biostatistics components of regulatory submissions, including NDA/BLA/MAA filings. Your leadership will foster a culture of inclusivity, collaboration, and agility, providing mentorship to your team and guiding consistent statistical approaches across various teams and locations.
This position is ideally based in the Bay Area (San Francisco, CA). Consideration will be given first to internal talent located hybrid-Cambridge or RTP, or US Remote for the ideal fit. This position will report into the Head of Biometrics for the Biogen WCH and will manage a team of Director-level and individual contributor direct reports.
What You’ll Do:
· Develop and oversee activities within the Biostatistics function for assigned therapeutic areas, ensuring high-quality and timely deliverables.
· Serve as a key member of the WCH Biometrics leadership team, contributing to the vision and goals of Biostatistics and the West Coast Hub Biometrics organization.
· Manage performance and career development of staff, fostering an engaging and collaborative culture.
· Enhance collaboration with other functional areas within Biometrics to drive innovations and overall productivity.
· In addition to partnering with West Coast Hub Statistical Programming and Data Management, establish relationships and ways of working with Biostatistics and other quantitative science colleagues in the broader Biogen organization
· Engage with other R&D functions to set drug development strategies that increase success probability.
· Represent the company in biostatistical interactions with regulatory agencies, corporate partners, and CROs.
· Lead cross-functional initiatives representing Biometrics and participate in key R&D governance meetings.
Who You Are: You are a visionary leader with a deep understanding of statistical principles and clinical trial methodologies. 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 developing your team and driving success in a fast-paced environment.
Required Skills:
· PhD in Biostatistics/Statistics or equivalent with a minimum of 14 years relevant work experience or MS in Biostatistics/Statistics or equivalent with a minimum of 16 years relevant experience.
· Broad understanding of statistical principles and clinical trial methodology.
· Experience in meeting FDA and international regulatory guidelines.
· Knowledge of medical/biological terminology and clinical practice in relevant therapeutic areas.
· Proven track record of staff development and effective people management.
· Strong ability to motivate and ensure productivity under ambiguous conditions.
· Leadership skills in proactive strategy setting, priority evaluation, and conflict resolution.
Preferred Skills:
· Experience in cross-functional drug development strategies, e.g., indication selection, clinical development planning, go/no-go decision-making, strategic and technical governance review, late-stage execution, etc.
· Ability to partner with clinicians, scientists and leadership from other functions (data-facing and otherwise).
· Ability to develop fit-for-purpose innovative statistical solutions to meet development program needs. Deep early and late-stage development experience across multiple therapeutic areas indications.
· Filing experience in multiple global health authority jurisdictions.
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 our DE&I efforts.
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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
