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Statistical Programmer Consultant

Role overview

Qualifications

  • Bachelor’s, Master’s in Statistics, Biostatistics, Computer Science, Mathematics, or a highly related Scientific discipline.
  • 8+ years of statistical programming 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).
  • Comprehensive understanding of CDISC standards and experience generating regulatory package artifacts.

Responsibilities

  • Act as the lead programmer for assigned clinical trial(s) and provide expert input and statistical programming support.
  • Lead the strategic design, creation, mapping, and validation of comprehensive SDTM and ADaM datasets.
  • Perform statistical analysis, program and validate Tables, Listings, and Figures (TLFs) using SAS.
  • Review and ensure high quality of CDISC packages and perform other duties as assigned.

Key facts

Hard skills

Other skills

  • Communication
  • Analytical Thinking
  • Problem Solving
  • Time Management
  • Teamwork

About the company

Kyverna Therapeutics logo

Kyverna Therapeutics

Biotechnology

Kyverna is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience.

Company details

IndustryBiotechnology
Company size51-200

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Job description

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
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    MR

    Marcus Rivera

    Chief Revenue Officer

    m.rivera@company.com
    linkedin.com/in/marcusrivera
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