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Vice President, Biometrics

Annexon BioscienceSouth San Francisco, California, United StatesRemote, Onsite
This job is no longer open

Work Location


Corporate Headquarters (South San Francisco, CA) – HybridNon-local candidates will be considered

Position Summary


We are seeking a dynamic and experienced Vice President of Biometrics to lead our Biometrics team. The successful candidate will provide strategic direction and operational oversight for all aspects of biostatistics, statistical programming, modeling and simulation, and advanced analytics within our organization. This role offers an exciting opportunity to contribute to the advancement of novel therapeutics and shape the future of biopharmaceutical research. Like all Annexon leaders, the VP of Biometrics incumbent will have a deep-rooted commitment to serving patients and a passion for transforming the lives of people with serious diseases and their families.

Responsibilities


Strategic Leadership:

  • Develop and execute the overall biometrics strategy in alignment with corporate goals and objectives
  • Provide leadership and guidance to the Biometrics team, fostering a culture of innovation, collaboration, and excellence.

Clinical Trial Support:

  • Oversee the design, planning, and implementation of statistical methodologies for clinical trials, ensuring accuracy and compliance with regulatory requirements.
  • Collaborate with cross-functional teams to develop and review study protocols, statistical analysis plans, and data collection processes.

Statistical Analysis and Reporting:

  • Lead the statistical analysis and interpretation of clinical trial data, including efficacy and safety outcomes.
  • Prepare and review statistical reports, summaries, and regulatory submissions for investigational and marketing applications.

Regulatory Compliance:

  • Ensure compliance with regulatory guidelines, standards, and industry best practices related to biometrics activities.
  • Represent the company in interactions with regulatory agencies and support regulatory submissions as needed.

Team Development:

  • Recruit, mentor, and develop a high-performing team of biometrics professionals.
  • Provide training, guidance, and support to enhance individual and team capabilities.

Requirements


  • Advanced degree (Ph.D. or M.S.) in biostatistics, statistics, or a related field
  • Extensive experience - at least 10 – 15 years in biometrics roles within the biopharmaceutical industry, including leadership positions
  • In-depth knowledge of statistical methodologies, clinical trial design, and regulatory requirements (e.g., FDA, EMA)
  • Strong understanding of data management principles, tools, and technologies.
  • Excellent leadership, communication, and interpersonal skills
  • Proven ability to effectively manage multiple projects and priorities in a fast-paced environment
  • Demonstrated strategic thinking and problem-solving abilities
  • Experience with adaptive trial designs and complex statistical modeling techniques including, but not limited to, proportional odds, Bayesian analyses, and real-world evidence studies
  • Familiarity with software platforms commonly used in biometrics (e.g., SAS, R)
  • Track record of successful regulatory submissions and interactions.
  • Ability to travel
  • Location: This position is based at our headquarters in South San Francisco, CA, with the possibility of remote work flexibility.

What Annexon offers


  • Diversity, Equity, Inclusion, and Belonging are important to us. We believe that diversity, equity, inclusion and belonging are essential for the strength of our business and the vitality of the communities we serve. To learn more about our diversity commitment, culture and values, visit https://annexonbio.com/careers/
  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
  • We are located in Brisbane, CA, with 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, as well as other benefits.

Company Summary


Annexon Biosciences (Nasdaq: ANNX) is 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. Annexon’s 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, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.

EEO Employer – Annexon highly values Diversity, Equity, Inclusion and Belonging


Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.Staffing AgenciesAnnexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences.

Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees.  Inquiries must be sent to  talentacquisition@annexonbio.com with the Subject Heading:  Staffing Agency Request.

This job is no longer open

Life at Annexon Bioscience

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. Our pipeline is based on our platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Our first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. Our second product candidate, ANX007, is a monoclonal antibody antigen-binding fragment (Fab) formulated for intravitreal administration for the treatment of neurodegenerative ophthalmic disorders. Based on learnings from our initial trials, we are advancing our current programs while evaluating additional orphan and large market indications. We are deploying a disciplined, biomarker-driven development strategy designed to establish that each of our product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
Thrive Here & What We Value- Diversity, Equity, Inclusion, and Belonging are important to Annexon Biosciences- Flexible Work Schedules and Remote Opportunities- Ability to Achieve a Work-Life Balance- Commitment to serving patients with serious diseases and their families- Emphasis on innovation, collaboration, and excellence- Diversity, Equity, Inclusion, and Belonging are essential for business strength and community vitality- Competitive base salary and equity participation, comprehensive health benefits package- Annexon Biosciences values a diverse, equitable, and inclusive workforce- Located in Brisbinas, CA with shuttle service from major transportation hubs
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