Associate Director, Statistical Programming

Responsibilities

• Manage timelines and provide sponsor oversight for statistical programming deliverables outsourced to biometrics vendors (CROs) with full E2E traceability.
• Serve as lead statistical programmer on one or more clinical studies.
• Conducts gap analysis and risk assessments for global submissions such as BLA/MAA etc.
• Reviews SAP, TFL shells, eCRFs etc.
• Maintain complete and auditable documentation for all statistical programming activities.
• Develop and/or verify CDISC SDTM/ADaM specifications, datasets and eCRT submission packages such as define.xml, reviewer’s guide’s etc.
• 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.

Requirements

• 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.
• Techical expertise and knowledge of experimental design and analyses using statistical software such as SAS etc.
• Understanding of GCP, ICH, 21 CFR Part 11 standards.

Qualifications

• 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 setting.
• Understanding of regulatory submission and approval process.
• Ability to effectively collaborate and influence throughout multiple levels of the organization.
• Strategic and creative drug-development mindset/approach.
• Awareness of external industry landscape with respect to best practices and emerging topics.

Skills

• 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 setting.
• Understanding of regulatory submission and approval process.
• Ability to effectively collaborate and influence throughout multiple levels of the organization.
• Strategic and creative drug-development mindset/approach.
• 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.

Pay

$194,000 - $216,000

Schedule

Flexible work schedule available.

Location

Brisbane, California