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Senior Director, Biostatistics

10-15 years
$272,000 to $302,000 per year
10 July 18, 2025
Job Description
Job Type: Full Time Education: PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Senior Director, Biostatistics

Location: San Francisco Bay Area (On-site – Brisbane, California)
Company: Annexon Biosciences
Salary Range: $272,000 to $302,000 per year
Employment Type: Full-Time, On-site
Experience Required: PhD with 10+ years OR MS with 15+ years in pharmaceutical/biotech


Job Summary:

Annexon Biosciences is seeking a strategic and experienced Senior Director of Biostatistics to lead and evolve its biostatistics function. In this high-impact leadership role, you’ll drive statistical strategy and execution across clinical development programs aimed at treating neuroinflammatory diseases. If you bring deep regulatory knowledge, advanced statistical expertise, and a passion for innovation, join us on-site in the San Francisco Bay Area.


Key Responsibilities:

  • Set the vision and strategy for the Biostatistics team

  • Lead and mentor statisticians across development programs

  • Oversee statistical deliverables for protocols, SAPs, analyses, reports, and submissions

  • Advise executive leadership on statistical methodologies and innovative design approaches

  • Represent the company in regulatory meetings and interactions

  • Collaborate cross-functionally with Clinical Development, Regulatory Affairs, and Data Management

  • Guide statistical operations, SOP development, and best practice frameworks

  • Ensure rigorous oversight of outsourced biometrics vendors

  • Support submission strategy and lead biostatistical input in regulatory filings


Required Skills & Qualifications:

  • PhD in Statistics or related field with 10+ years OR MS with 15+ years in pharma/biotech

  • Proven experience in leading drug development programs through regulatory approval

  • Strong understanding of FDA/EMA/ICH guidelines and global regulatory processes

  • Expertise in advanced statistical methods (e.g., Bayesian methods, adaptive designs)

  • Excellent communication and leadership skills, with the ability to influence at all levels

  • Demonstrated ability to build and lead high-performing teams

  • Experience managing CRO relationships and statistical outsourcing models

  • Ability to work effectively in a fast-paced, innovative environment


Preferred Skills:

  • Deep experience in modeling & simulation, real-world evidence, precision medicine

  • Strong business acumen and emotional intelligence

  • Strategic thinking with the ability to challenge conventional processes

  • Awareness of industry trends in biostatistics and clinical development


Perks & Benefits:

  • Competitive salary and equity participation

  • Flexible work schedules and work-life balance

  • Shuttle service from BART, CalTrain, and Ferry terminals

  • Comprehensive health benefits (medical, dental, vision)

  • 401(k), FSA, and employee stock purchase plan

  • Inclusive, diverse, and collaborative workplace culture


Company Overview:

Annexon Biosciences is a Nasdaq-listed biopharmaceutical company headquartered in Brisbane, CA. We are pioneers in complement pathway inhibition, advancing therapies for classical complement-mediated neuroinflammatory diseases. With a mission-driven culture and an advancing clinical pipeline, Annexon is redefining neuroimmunology-based drug development.


Work Mode:

On-site (San Francisco Bay Area – Brisbane, CA preferred)


Call to Action:

Are you ready to lead statistical innovation and accelerate breakthrough therapies? Apply today to join Annexon Biosciences and make an impact in the future of immunology and neuroscience.