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Senior Statistical Programmer Analyst
Arcus BiosciencesSenior Statistical Programmer Analyst Contractor responsible for supporting submission readiness of study data packages at Arcus Biosciences. Collaborating with biostatisticians and clinical data managers on statistical programming and analyses.
Tech Stack
Tools & technologiesGoogle Cloud PlatformPythonUnix
About the role
Key responsibilities & impact- The Senior Statistical Programmer Analyst Contractor will be responsible for supporting the submission readiness of study data packages per CDISC standards and FDA guidance, planning, execution, and quality of statistical analyses, and statistical programming infrastructure.
- This position will report into Head of Statistical Programming and will interact regularly with internal and external biostatisticians, clinical data managers, and other team members.
- Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
- Manage on-time and quality delivery of CRO-generated analyses results.
- Responsible for creating/reviewing SDTM/ADaM mapping specifications. Generates or validates SDTM domains, ADaM datasets, reviewer's guide, and define.xml files.
Requirements
What you’ll need- Bachelor’s or Master’s degree in a data science field, e.g., statistics, mathematics, epidemiology, computer science, bioinformatics, or another field with commensurate levels of experience
- 8 + years programming experience with growing responsibility in biotechnology or pharmaceutical clinical trial environment.
- Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, Unix scripts etc).
- Experts in developing applications using various technical stacks not limited to SAS, R and/or Python.
- Solid understanding of industry standards such as CDISC, specifically SDTM and controlled terminology and/or ADaM.
- Proven ability to translate sophisticated problems into clear and concise programming code/tools.
- Basic Project management skills and experience.
- Solid understanding of programming practices (including tools and processes), relevant health authority guidelines, such as (e.g., ICH‐GCP, 21 CFR Part 11), and relevant clinical R&D concepts.
- Demonstrated strong written, verbal communication skills, ability to manage conflicting demands and priorities and to negotiate successfully.
Benefits
Comp & perks- Health insurance
- Professional development opportunities
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
statistical programmingSASRPythonSAS MacrosUnix scriptsSDTMADaMdata analysisprogramming code
Soft Skills
communication skillsproject managementproblem-solvingnegotiationtime managementteam collaborationattention to detailadaptabilityconflict resolutionorganizational skills