Associate Director, Statistical Programming

Associate Director, Statistical Programming

At Annexon Biosciences, a biopharmaceutical company dedicated to developing therapies for complement‑mediated neuroinflammatory diseases, we are seeking an experienced Statistical Programming professional to lead and oversee the development and delivery of statistical programming solutions across our clinical trials and regulatory submissions.

Responsibilities

• Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full end‑to‑end traceability.
• Serve as lead statistical programmer on one or more clinical studies.
• Conduct gap analysis and risk assessments for global submissions such as BLA/MAA.
• Maintain complete and auditable documentation for all statistical programming activities.
• Develop and/or verify CDISC SDTM/ADaM specifications, datasets, and eCRF submission packages such as define.xml and reviewer’s guide.
• Support supplemental/ad hoc/post‑hoc requests for submissions, publications, and manuscripts.
• Provide guidance to project/study teams.
• Participate cross‑functionally with key partners to advance Annexon products.
• Contribute to and participate in the development and maintenance of a positive team‑focused company culture.

Qualifications

Required

• MS with 8+ years of experience or BS with 10+ years of experience in the pharmaceutical or biotechnology industry in a Statistical Programming leadership capacity.
• In‑depth knowledge of CDISC standards.
• Prior FDA and EMA submissions experience.
• Technical expertise and knowledge of experimental design and analyses using statistical software such as SAS.
• Understanding of GCP, ICH, 21 CFR Part 11 standards.
• Ability to work in a dynamic, demanding, and collaborative environment.

Preferred

• Ability to communicate with clarity and influence, including explaining complex quantitative issues in simple terms.
• Solid understanding of Regulatory (FDA/EMA/ICH) guidance with the ability to interpret and apply in real‑time drug‑development settings.
• Understanding of regulatory submission and approval processes.
• Ability to effectively collaborate and influence throughout multiple levels of the organization.
• Strategic and creative drug‑development mindset/approach.
• 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: $194,000 - $216,000 USD

Location: Brisbane, California (preferentially candidates in the San Francisco Bay Area)

Benefits

• Flexible work schedules, remote opportunities, and a focus on work‑life balance.
• Shuttle service from BART, CalTrain, and the ferry.
• Competitive base salary and equity participation, employee stock purchase plan, and comprehensive health benefit package including medical, dental, vision, 401(k), and flexible spending plans.

Annexon Biosciences is an Equal Opportunity Employer. We prohibit discrimination or harassment of any kind and are committed to fostering an inclusive environment where all employees are respected for their individual strengths and viewpoints. We do not discriminate on the basis of any protected group status under applicable law.