Director, Biostatistics, WCH
Biogen
September 01, 2026
On-site
San Francisco, CA
Clinical Research and Development
Director of Biostatistics, West Coast Hub (WCH) — ideally based in the Bay Area (San Francisco, CA).
Responsibilities:
- Provide statistical leadership and accountability for biostatistics activities/deliverables for one or more late-stage nephrology clinical development projects.
- Act as indication Biostatistics Lead; direct evidence generation and clinical development strategy/execution.
- Develop and oversee overall statistical activities to ensure high-quality, timely deliverables.
- Supervise/coaching biostatisticians (staff development and mentorship) and represent Biostatistics on cross-functional governance/project/regulatory teams.
- Provide guidance/oversight/direct input on clinical development plans, protocols, analyses, clinical study reports, and regulatory submission materials.
- Address statistical issues related to regulatory/legal challenges and represent the company in regulatory meetings, scientific conferences, or with KOLs.
- Lead/process-improvement initiatives to drive innovation and consistent statistical approaches.
Required Skills/Qualifications:
- PhD in Biostatistics/Statistics (or equivalent)
- 8+ years in pharmaceutical/biotech industry
- Deep understanding of statistical principles, clinical trial methodology, and drug development
- Ability to create innovative statistical/technical solutions
- Statistical project leadership in late-stage clinical development strategy/execution
- Experience with FDA and international regulatory guidance
- Knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
- Strong verbal/written communication and leadership; strategic priority setting and conflict resolution
Preferred Skills:
- Regulatory experience (FDA/EMA/PMDA) and BLA/NDA/MAA submission
- Nephrology or immunology experience
- People manager with staff-development track record
Compensation/Benefits (as listed):
- Base compensation range: $209,000–$288,000; incentives may apply.
- Medical/Dental/Vision/Life; fitness reimbursement; disability; 15+ days paid vacation + shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups.
Responsibilities:
- Provide statistical leadership and accountability for biostatistics activities/deliverables for one or more late-stage nephrology clinical development projects.
- Act as indication Biostatistics Lead; direct evidence generation and clinical development strategy/execution.
- Develop and oversee overall statistical activities to ensure high-quality, timely deliverables.
- Supervise/coaching biostatisticians (staff development and mentorship) and represent Biostatistics on cross-functional governance/project/regulatory teams.
- Provide guidance/oversight/direct input on clinical development plans, protocols, analyses, clinical study reports, and regulatory submission materials.
- Address statistical issues related to regulatory/legal challenges and represent the company in regulatory meetings, scientific conferences, or with KOLs.
- Lead/process-improvement initiatives to drive innovation and consistent statistical approaches.
Required Skills/Qualifications:
- PhD in Biostatistics/Statistics (or equivalent)
- 8+ years in pharmaceutical/biotech industry
- Deep understanding of statistical principles, clinical trial methodology, and drug development
- Ability to create innovative statistical/technical solutions
- Statistical project leadership in late-stage clinical development strategy/execution
- Experience with FDA and international regulatory guidance
- Knowledge of medical/biological terminology and clinical trial design in relevant therapeutic areas
- Strong verbal/written communication and leadership; strategic priority setting and conflict resolution
Preferred Skills:
- Regulatory experience (FDA/EMA/PMDA) and BLA/NDA/MAA submission
- Nephrology or immunology experience
- People manager with staff-development track record
Compensation/Benefits (as listed):
- Base compensation range: $209,000–$288,000; incentives may apply.
- Medical/Dental/Vision/Life; fitness reimbursement; disability; 15+ days paid vacation + shutdown; holidays; sick time; paid maternity/parental leave; 401(k) match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups.