Senior Statistical Programmer Analyst

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🖥 Software Engineer

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Arcus Biosciences

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Arcus Biosciences is a rapidly growing, clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer.

📋 Description

• 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

• 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

• Health insurance • Professional development opportunities