Head of Biostatistics
Annexon Biosciences is a private, clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, eye and brain. The Company’s pipeline is based on its 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. The Company’s first product candidate, ANX005, is a full-length monoclonal antibody formulated for intravenous administration in autoimmune and neurodegenerative disorders. The Company’s 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 its initial trials, Annexon is advancing its current programs while evaluating additional orphan and large market indications. Annexon is deploying a disciplined, biomarker-driven development strategy designed to establish that each of its product candidates is engaging the specific target at a well-tolerated therapeutic dose in the intended patient tissue.
Department Head responsible for overseeing the global design and development of the biostatistics function, translating the development strategies into tactical plans to support product development objectives. This individual will lead the Biostatistics function across all therapeutic areas of Annexon. The individual will be responsible for providing statistical input to development strategies, and the formulation of effective implementation plans to support product development objectives. Provide expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing strategy, study design and analyses, and will institute best practices for planning, execution, and interpretation of clinical projects and studies.
Major Duties and Responsibilities:
Responsibilities will include, but are not limited to, the following:
• Leads, initiates, and oversees the statistical support for the development of multiple compounds within a therapeutic area in close collaboration with Clinical Development, Regulatory Affairs, Clinical Pharmacology.
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Manages resources, sets priorities, and ensures consistency and adherence to standards therein.
• Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses.
• Contributes to creation/maintenance of and provides training on statistical topics and departmental SOPs.
• Resolves technical, quality, and timeline issues.
• Identifies external statistical experts for consultation.
• Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests.
• Represents the company in interfaces with regulatory agencies globally.
• Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals.
• Interacts and manages KOLs/CROs and represents the company in external scientific forums.
• Represents Biostatistics function at project meetings.
• Act as a resource/mentor to study team members.
• Informs the long-term Biostatistics strategy and structure.
• Ph.D. in statistics or related field.
• Experience in clinical drug development, 10+ years for Ph.D.
• Demonstrated skill in the planning, analysis and reporting of clinical trials.
• Detailed knowledge of statistical methodologies and statistical regulatory requirements.
• Previous direct supervisory experience of statisticians.
• Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills.
• In-depth knowledge of all phases of the drug development process.
• Demonstrated ability to work in a team environment.
• Good interpersonal, communication, writing and organizational skills.
• Demonstrated skill in resource management, both internal and external resources.
• Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards.
• Abreast of clinical trial development and regulatory requirements for relevant therapeutic areas.