Senior Director, Biostatistics

Company: 

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.   

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA. 

We're seeking exceptional talent from all backgrounds to fuel our growth. At Annexon, we're building a diverse, equitable, and inclusive workplace. We value unique perspectives and unconventional paths. If you're the best candidate for the job, even if you don't perfectly fit the traditional mold, we encourage you to apply. Learn more about our commitment to diversity, equity, inclusion, and our company culture! 

Position: 

The Senior Director, Biostatistics at Annexon is an influential leader overseeing a team of statisticians responsible for clinical development/submission strategy and clinical trial analysis methodology. A highly empowered, visible and collaborative role, the Senior Director, Biostatistics partners with, clinical and regulatory experts to advance medicines to our patients. This role reports to the SVP, Biometrics. 

Responsibilities include: 

• Establish the vision for Biostatistics by building and maintaining a high performing organization that serves as a key strategic partner within Annexon 
• Lead and oversee project level statisticians, providing operational, strategic, and technical guidance while ensuring accountability for all statistical deliverables, including, development plans, protocols, SAPs, analyses, reports, and regulatory submissions within Annexon  
• Serve as methodological expert providing guidance to statisticians, teams and executive leadership 
• Ensure scientifically sound development strategies that incorporate both current best practices and innovative approaches. Propose and implement optimal methodologies including accelerated, Bayesian or seamless designs 
• Represent Annexon at key regulatory meetings and/or FDA advisory committee meetings or deploy qualified staff as appropriate 
• Serve on the Biometrics leadership team to provide guidance on direction and operations of the department 
• Define, advance and codify the department’s procedural framework including the operating model, process definitions, SOPs, and best practices   
• Collaborate cross-functionally with key partners to drive the advancement of Annexon products, contributing to data acquisition, study quality activities, regulatory reporting and communications, publication planning and support and data interpretation 
• Ensure appropriate oversight of Biometrics outsourced activities 
• Contribute to and participate in the development and maintenance of a positive team-focused company culture 

Education, Experience, and Skills: 

Required: 

• PhD in statistics or related field with 10+ years (or MS with 15+ years) of experience in the pharmaceutical or biotechnology industry 
• Experience leading product development programs through submission and approval 
• Demonstrated expertise in advanced statistical methods (e.g. Adaptive designs, Bayesian methods, real world evidence, multiplicity, subgroup identification, precision medicine, modeling & simulation etc.) 
• Deep understanding of Regulatory guidelines (FDA/EMA/ICH) and the submission and approval process, with the ability to interpret and apply them in real-time drug development settings 

Preferred:  

• Experience building and leading high performing teams; and identifying, attracting, developing, and retaining top talent
• Ability to communicate with clarity and influence executives, regulators, and key stakeholders, including translating complex quantitative issues in simple, understandable terms 
• Experience with clinical trial outsourcing models and associated GCP oversight 
• Leadership acumen including emotional intelligence and business awareness
• Strong ability to collaborate and influence at all levels of the organization, coupled with excellent judgement in negotiation – balancing compromise, standing firm, or identifying alternative solutions
• Strategic and innovative approach to drug-development, with a willingness to challenge the status quo 
• Ability to balance appropriate levels of structure/process with efficiency and simplicity 
• Awareness of external industry landscape with respect to best practices and emerging topics 

Salary Range: $272,000 to $302,000

Location: Annexon Biosciences is located in Brisbane, California and preference is given to candidates in the San Francisco Bay Area. This position will be on-site.

Benefits: 

• A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
• Shuttle service from BART, CalTrain and the Ferry.
• Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, and other benefits. 

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.