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.
This candidate will develop all aspects of statistical programming deliverables for the analysis of clinical study data in accordance with departmental SOPs and guidelines. This includes generating/validating analysis datasets, tables, listings, and figures for clinical trials; creating SDTM mapping and datasets; developing and maintaining the infrastructure for project files of the datasets and programming code; supporting Data Management in data set creations/transfers, integrity checks, and quality audits; acting as a liaison between clinical and subcommittees and project teams on an as-needed basis.
Responsibilities- Lead the development and implementation of programming standards, SOPs and work instructions, including program/data validation and documentation, to generate displays of clinical study data as tables, listings, and graphs to support data monitoring, exploration, publication, committee meetings, and electronic submission to regulatory agencies.
- Create or review and approve CDISC-compliant datasets (SDTM, ADaM) and corresponding documentation for electronic submission to regulatory agencies.
- Oversight of CRO on timelines, assign and follow up on programming tasks, interact with CRO and stakeholders, and ensure quality of programming deliverables.
- Create and review and approve statistical programming plans at study and project level. Provide input on key study-related documents produced by other functions (e.g. study protocols, CRFs, Data Management Plan, SAPs, etc.).
Requirements- M.Sc., M.A. or higher degree in Statistics, Biostatistics, Computer Science, or relevant fields.
- 10 (M.Sc., M.A.)/8 (Ph.D.) years’ related experience.
- Expert knowledge of CDISC SDTM and ADaM data models. Familiarity with clinical trial design, analysis activities, regulatory guidelines.
- Must possess in-depth understanding of the concept of standardization in data, programming, and statistical reporting of trial results, and its implication to the relevant functions and operations.
- In-depth knowledge of clinical trial data processing and manipulation, hands on statistical programming and analysis, requirements for assembling and presenting trial results to regulatory agencies.
- Proficiency in SAS and R.
- Very strong interpersonal communication, presentation, and leadership skills.
The salary range for this position is from $145,000 - $185,000 USD 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 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 identity, 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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