Director, Biostatistics

Biogen

. Provide statistical leadership and accountability for biostatistics activities and deliverables for late-stage nephrology clinical development projects .

Posted 10/8/2026full-timeSan Francisco • California • United StatesLead💰 $209,000 - $287,750 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics leadership, clinical development strategy, and regulatory compliance, with a strong focus on mentoring and developing statistical teams. Proven ability to innovate and improve processes in late-stage clinical trials, particularly in nephrology and immunology.

Highest-signal resume keywords

PhD In Biostatistics/Statistics8+ Years Pharmaceutical/Biotech ExperienceStatistical Project LeadershipRegulatory Guidance KnowledgePeople Management Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Statistical PrinciplesClinical Trial MethodologyStatistical Solutions DevelopmentClinical Development PlansRegulatory Submission Materials

Soft Skills

Strong Verbal CommunicationStrong Written CommunicationLeadership SkillsConflict ResolutionEffective Partnership

Industry Keywords

NephrologyImmunologyFDAEMAPMDABLANDAMAAClinical Trial DesignMedical Terminology

About the role

Key responsibilities & impact

Provide statistical leadership and accountability for biostatistics activities and deliverables for late-stage nephrology clinical development projects
Act as indication Biostatistics Lead for clinical development and evidence generation strategy and execution
Direct contributions and provide oversight for clinical development plans, protocols and analyses, clinical study reports, and regulatory submission materials
Ensure adherence to regulatory guidelines and scientific rigor
Coach and supervise statisticians working on assigned projects
Build and maintain collaboration with stakeholders across disciplines
Represent Biostatistics on cross-functional teams, governance committees, regulatory agency meetings, and advisory boards
Provide mentorship to biostatisticians in the department
Drive innovation and process improvement to enhance technical capabilities
Develop and direct overall statistical activities for assigned projects, ensuring high-quality and timely deliverables
Provide guidance, supervision, coaching, and staff development for project biostatisticians
Provide input into clinical development strategy, planning, regulatory submissions, and evidence generation
Address statistical issues in regulatory, legal, or other challenges
Represent the company in regulatory meetings, scientific conferences, and meetings with key opinion leaders
Lead or participate in clinical development innovation and process improvement initiatives
Provide broader mentoring and leadership to achieve organizational missions and goals

Requirements

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 experience 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, conflict resolution, and effective partnership
Preferred: Past regulatory experiences, including interactions with FDA/EMA/PMDA and BLA/NDA/MAA submission experiences
Preferred: Experience in nephrology or immunology
Preferred: People management experience with a track record of staff development

Benefits

Comp & perks

Short-term and long-term incentives, including cash bonus and equity incentive opportunities
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
Minimum of 15 days of paid vacation
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