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Senior Director, Biostatistics
@Annexon Biosciences
[Hiring] Senior Director, Biostatistics @Annexon Biosciences
Mar 31, 2025 - Annexon Biosciences is hiring a remote Senior Director, Biostatistics. 💸 Salary: $272,000 to $302,000. 📍Location: USA.
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Role Description
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.
- 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
Qualifications
- 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
Requirements
- 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
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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
$272,000 to $302,000
|
Remote
Location
USA
|
|
Job Type
unspecified
|
Posted
Mar 31, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
