Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The Kyverna therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the origin of autoimmune and inflammatory diseases. Be at the forefront of cell therapy innovation by joining scientists, industry veterans and healthcare visionaries and help transform how autoimmune diseases are treated
Title: Senior Manager / Associate Director, Statistical Programming
Reporting to: VP, Quantitative Sciences
Location: Remote
Kyverna is recruiting a Senior Manager / Associate Director, Statistical Programming in its Quantitative Sciences organization to help advance its mission to free patients from the siege of autoimmune disease. The ideal candidate will contribute to our goals of navigating what’s next in synthetic biology, immunology and cell engineering while living our core values: bring intellectual humility, elevate each other, and stay true to why.
As we expand our team, we are seeking our first in-house Senior Manager / Associate Director of Statistical Programming to play a pivotal role in our regulatory submissions and statistical programming activities. This newly created role will be responsible for establishing and leading Kyverna’s in-house statistical programming function, ensuring compliance with CDISC standards and overseeing the work of external CRO partners. The successful candidate will take ownership of critical statistical programming deliverables, including the Biologics License Application (BLA) filing, and will ensure the integrity, consistency, and quality of clinical data submissions.
Responsibilities:
- Lead statistical programming efforts to support regulatory submissions, with a strong focus on the BLA filing.
- Oversee and verify the work performed by Contract Research Organizations (CROs) to ensure compliance with CDISC, ADaM, and SDTM data standards.
- Provide technical expertise in the implementation of statistical programming best practices, including quality control procedures.
- Ensure timely delivery of statistical programming outputs, including analysis datasets, tables, listings, and figures (TLFs) for clinical trials.
- Collaborate cross-functionally with Clinical Development, Biostatistics, Regulatory Affairs, and Data Management to support clinical study reporting and regulatory submissions.
- Lead the development and validation of standard macros, templates, and programming guidelines to enhance efficiency and compliance.
- Identify and resolve programming and data issues in collaboration with internal and external stakeholders.
- Maintain up-to-date knowledge of relevant regulatory guidelines and industry best practices for statistical programming.
Requirements:
- Bachelor’s or Master’s degree in Biostatistics, Computer Science, Data Science, or a related field.
- 8+ years of hands-on statistical programming experience in the biotechnology or pharmaceutical industry.
- Expert knowledge of CDISC standards (ADaM, SDTM) and experience ensuring regulatory compliance.
- Strong SAS programming skills and experience with R or other statistical programming languages.
- Proven experience overseeing and validating CRO deliverables.
- Track record of successful participation in regulatory submissions, including BLA filings.
- Strong problem-solving skills with a detail-oriented approach.
- Ability to work independently in a fast-paced, dynamic environment while collaborating effectively across teams.
The salary range for candidates residing in California for this position is $170,000 to $ 208,000 annually. This salary range is an estimate of what we reasonably expect to pay for this posted position, and the actual salary may vary based on various factors, including without limitation geographic location, individual education, experience, tenure, skills and abilities, as well as internal equity and alignment with market data. This position is also eligible for bonus, benefits, and participation in Company’s stock option plan.
Kyverna is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Kyverna is committed to the principle of equal employment opportunity for all employees and does not discriminate on the basis of race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets
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Last updated on Feb 3, 2025