Associate Director, Statistical Programming

Responsibilities

• Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs)
• Serve as lead statistical programmer on one or more clinical studies
• Conduct gap analysis and risk assessments for global submissions such as BLA/MAA
• Review SAP, TFL shells, and eCRFs
• Maintain complete and auditable documentation for all statistical programming activities
• Develop and verify CDISC SDTM/ADaM specifications, datasets, and eCRT submission packages
• Support supplemental, ad hoc, and post hoc requests for submissions, publications, and manuscripts
• Provide guidance to project and study teams

Requirements

• MS with 8+ years of experience or BS with 10+ years of experience in pharmaceutical or biotechnology industry
• Leadership experience in Statistical Programming
• In-depth knowledge of CDISC standards
• Prior FDA and EMA submissions experience
• Technical expertise in SAS and experimental design/analyses
• Understanding of GCP, ICH, and 21 CFR Part 11 standards

Preferred Qualifications

• Ability to communicate complex quantitative issues in simple terms
• Solid understanding of Regulatory (FDA/EMA/ICH) guidance
• Understanding of regulatory submission and approval processes
• Strategic and creative drug-development mindset

Benefits

• Flexible work schedules and remote opportunities
• Shuttle service from BART, CalTrain, and the Ferry
• Competitive base salary and equity participation
• Employee stock purchase plan
• Comprehensive health benefit package (medical, dental, vision, 401(k), flexible spending plans)

About the Company

Annexon Biosciences 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.