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Statistical Programmer Consultant
Kyverna Therapeutics. Act as the lead programmer for assigned clinical trials and work closely with the study statistician, clinical data management, and other study-team functions.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in statistical programming and data management for clinical trials, with advanced proficiency in SAS and a comprehensive understanding of CDISC standards. Strong analytical, communication, and problem-solving skills are essential for managing multiple projects effectively in a collaborative environment.
Highest-signal resume keywords
Statistical Programming ExperienceAdvanced Proficiency In SASCDISC Standards KnowledgeClinical Trial Data ManagementStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Statistical ProgrammingSASData MappingStatistical AnalysisSDTM DatasetsADaM DatasetsPROC FREQPROC REPORTPROC SQLPROC MIXED
Soft Skills
Analytical SkillsProblem-Solving SkillsTime ManagementInterpersonal SkillsCollaboration
Tools & Technologies
Pinnacle 21Define.xmlECTD
Industry Keywords
Clinical TrialsBio/PharmaClinical Research OrganizationRegulatory Package ArtifactsACRF
Tech Stack
Tools & technologiesSQL
About the role
Key responsibilities & impact- Act as the lead programmer for assigned clinical trials and work closely with the study statistician, clinical data management, and other study-team functions.
- Lead the strategic design, creation, mapping, and validation of SDTM and ADaM datasets, ensuring data traceability.
- Perform statistical analysis and program and validate Tables, Listings, and Figures using SAS for Clinical Study Reports, Development Safety Update Reports, ad-hoc requests, and publications.
- Review and ensure the quality of CDISC packages, including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for eCTD submissions.
- Perform other duties as assigned.
Requirements
What you’ll need- 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 such as 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.