Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for patients suffering from autoimmune diseases. Guided by our core values, Stay True to Why, Collaborate to Accelerate, Lead with Clarity, Boldly Innovative, and Own the Outcome, we are committed to transforming the future of treatment for autoimmune disease. Join us at the forefront of cell therapy innovation and help redefine what’s possible.
Title: Statistical Programmer Consultant
Reports to: Director, Statistical Programming
Location: Remote (West coast hours preferred)
Duration: 6 months
Hours: 40/hrs per week
Hourly rate: $80-100/hr
Summary
We are seeking a Statistical Programmer Consultant to independently lead statistical programming activities and provide technical support for assigned clinical trial(s). This role combines study-level leadership, strong knowledge of clinical trial data, direct programming expertise to generate datasets, tables, listings, figures, and regulatory submission deliverables.
Responsibilities
- Act as the lead programmer for assigned clinical trial(s), and work closely with study statistician, clinical data management, and other functions within the study team to provide expert input and statistical programming support.
- Lead the strategic design, creation, mapping, and validation of comprehensive SDTM and ADaM datasets, ensuring flawless execution of data traceabilities.
- Perform statistical analysis, program and validate Tables, Listings, and Figures (TLFs) using SAS to support Clinical Study Reports (CSRs), Development Safety Update Report (DSUR), ad-hoc requests, and publications.
- Review and ensure high quality of CDISC packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML meeting CDISC standards and regulatory requirements as part of eCTD submission.
- Perform other duties as assigned.
Qualifications
- Bachelor’s, Master’s in Statistics, Biostatistics, Computer Science, Mathematics, or a highly related Scientific discipline.
- 8+ years of statistical programing experience within a bio/pharma company, or clinical research organization (CRO).
- Advanced proficiency in SAS (including complicated data steps, Macro language, and commonly used analysis procedures (e.g., PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED).
- Comprehensive understanding of CDISC standards and experience generating regulatory package artifacts like define.xml and Reviewer's Guides (cSDRG, ADRG).
- Strong communication, analytical, and problem-solving skills, with excellent time management and the ability to independently manage multiple high-priority projects in a fast-paced environment.
- Excellent interpersonal skills and the ability to collaborate effectively as part of a cross-functional team.
- Demonstrated ability to work independently, communicate proactively, and deliver results effectively in a remote work environment
Skills Required
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a closely related scientific discipline
- 8+ years of statistical programming experience within a biopharmaceutical company or clinical research organization
- Advanced proficiency in SAS, including complex data steps, macro language, PROC FREQ, PROC REPORT, PROC SQL, and PROC MIXED
- Comprehensive understanding of CDISC standards
- Experience generating regulatory package artifacts, including define.xml and cSDRG/ADRG reviewer guides
- Strong communication, analytical, problem-solving, and time-management skills
- Ability to independently manage multiple high-priority projects in a fast-paced environment
- Excellent interpersonal and cross-functional collaboration skills
- Ability to work independently, communicate proactively, and deliver results in a remote work environment
What We Do
Kyverna is a cell therapy company engineering and developing a new class of curative living medicines for inflammatory and autoimmune diseases. Using its SmarTcell™ approach which includes synReg-T cell and synNotch CAR-T technology platforms, Kyverna reprograms T cells to target and selectively suppress or eliminate autoreactive immune cells. The company’s goal is to develop therapies that are selective, potent and durable to tame autoimmunity. We build interdisciplinary teams that bring a broad range of experiences and scientific expertise together to develop medicines that will free patients from the siege of autoimmune diseases and bring curiosity for exploring and creating the unknown. Our commitment to our employees is to foster an open, supportive, and inclusive environment where we create opportunities for individuals to learn and grow to their full potential at every level. synNotch is a trademark of Gilead/Kite.
