Director, Statistical Programming

Position Summary:

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. 

Key Responsibilities include:

• 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

Not sure if you are qualified for this position?  We know that skills and experience can show up in different ways and we welcome resumes from a broad range of applicants.  You are encouraged to apply even if you do not meet each of the listed preferred qualifications. 

Preferred Qualifications Include:

• 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. Candidates with different combinations of experience and education will be considered and are encouraged to apply
• 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. An adaptable and creative mindset, paired with exceptional problem-solving skills, is essential to thrive and succeed at Kezar
• Fluent in the MS Office ecosystem
• Remote candidates will be considered; however, the preference is to be onsite at our South San Francisco, CA office at least three days per week. Assistance with relocation and / or work authorization is not available

Compensation and Benefits

This role can be based at our South San Francisco, CA corporate office (preferred) or remote-based.  The salary range for this position at our SSF office is $225,000 – 240,000.  For remote-based candidates, the salary range will be based on the local market, which varies state to state and is typically lower than the San Francisco Bay Area.  Additional factors such as academic credentials and relevant experience will influence the actual salary offered.  In addition to a competitive market-based salary, Kezar Life Sciences offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K.  Additional information about our total rewards program can be found here:  Join Our Team - Kezar Life Sciences Inc.

About Kezar Life Sciences

Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases.  Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases.

We are committed to cultivating a culture of trust, respect, and collaboration at every level.  We encourage employees to ask questions, share perspectives, and explore innovative solutions to tackle challenges. We embrace diverse ideas, styles, and approaches as essential to achieving our goals. Hard work, innovation, and compassion are core qualities we value in every Kezar employee, and we are always seeking dynamic, motivated individuals to join our team and help drive our mission forward.

Information for Recruitment Agencies

Kezar Life Sciences does not accept from recruiters/agencies any unsolicited resumes, or any candidate information including blinded resumes and will not be responsible for any fees related to resumes or candidate information that is unsolicited.  Please do not contact hiring managers or Kezar Life Sciences employees directly with any information related to a resume or a candidate.  We handle all recruiting through our internal Human Resources team, and we will reach out to you directly should we wish to engage in a search.  Your willingness to comply with this will significantly impact any decision we may make about doing business with you.