Director, Statistical Programming

Kezar Life Sciences • San Francisco, CA

312d • $225,000 - $240,000

About The Position

Reporting to Kezar's Sr. Director, Biostatistics, you will be a key member of the Biometrics team, responsible for critical deliverables related to data readouts, complex FDA submissions and advancement of new clinical trials.

Requirements

• A postgraduate degree in statistics, quantitative sciences, health economics, bioinformatics, epidemiology, or other relevant discipline combined with 10+ years of experience in coding and developing analytical datasets and conducting statistical analysis with clinical trials and real-world studies in the biopharmaceutical industry
• Proven experience in performing statistical programming using SAS® for creating and testing analysis datasets, tables, listings, and figures for Phase I-IV clinical trials
• Excellent technical and data analysis skills supported by exceptional attention to detail and organizational abilities
• Recognized as an in-house with CDISC (SDTM/ADaM) standards, specifications, documentation, QC and validation
• Familiarity with FDA submission guidelines, including regulatory requirements for clinical trial data (e.g., 21 CFR Part 11 compliance, FDA's guidance on statistical analysis, and clinical study data standards like CDISC, SDTM, ADaM)
• Outstanding interpersonal skills with a strong track record of collaboration across functions, including internal colleagues and external vendors, and a deep understanding of stakeholder roles and their connection to the biometrics team
• Must be flexible and able to prioritize and meet deadlines in a fast-paced environment while navigating setbacks and unexpected challenges
• Fluent in the MS Office ecosystem

Responsibilities

• Integration of data from multiple platforms to deliver cohesive, accurate insights
• Develop detailed project plans, including scopes, timelines, risk identification/mitigation, and cross-functional interdependencies
• Manage and direct vendors in the execution of statistical programming and data visualization tasks
• Proactively anticipate data visualization needs for key stakeholders and senior management
• Design, write, document, and test statistical programs using advanced programming techniques (e.g., macros, reusable functions, advanced SQL); ensure high-quality code requiring minimal review
• Demonstrated ability to interpret bio-statistical, epidemiological, and research results to provide actionable insights
• Provide review and revision of content for external communications, as needed
• Establish / maintain relevant procedures and processes to ensure that statistical programs are properly documented and validated to meet industry and regulatory standards
• Contribute to clinical study reports, regulatory submissions, and annual DSUR, IB update and safety reports
• Lead and perform required programming activities to support integrated summary of efficacy (ISE) and integrated summary of safety (ISS)
• Execute ad hoc and post hoc analyses to support clinical study reports (CSRs), conference presentations, and publication

Benefits

• Competitive market-based salary
• Opportunity to participate in stock programs
• Performance-based bonus
• Comprehensive benefits package including 401K

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Master's degree