Senior Statistical Programmer Analyst – Contractor

Arcus Biosciences · via Remote Communications Jobs

🌎 Remote ⌛ Posted 12 days ago

Support submission readiness of study data packages per CDISC standards and FDA guidance
Plan, execute, and ensure quality of statistical analyses
Support statistical programming infrastructure
Interact with internal and external biostatisticians, clinical data managers, and other team members
Prioritize work and communicate and collaborate with stakeholders across Biometrics, research, translational science, clinical science, clinical operations, and regulatory
Develop specifications and build and execute programs for internal data reviews, publications, exploratory and post-hoc analyses, and regulatory review
Produce and prioritize study-level or integrated analytical deliverables for safety signal detection and other business needs
Work with data management to review case report forms, database specifications, and data transfer specifications
Manage on-time and quality delivery of CRO-generated analysis results
Create and review SDTM/ADaM mapping specifications
Generate or validate SDTM domains, ADaM datasets, reviewer’s guides, and define.xml files
Generate or validate TFLs supporting clinical study analyses, regulatory submissions, and publications including CSR, DSUR, and IB

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
Minimum 8+ years programming experience with growing responsibility in a biotechnology or pharmaceutical clinical trial environment
Experience in software development and testing, including SAS Macros tools, R functions/packages, and Unix scripts
Expertise developing applications using technical stacks including SAS, R and/or Python
Solid understanding of CDISC industry standards, specifically SDTM, 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, relevant health authority guidelines such as ICH-GCP and 21 CFR Part 11, and relevant clinical R&D concepts
Strong written and verbal communication skills
Ability to manage conflicting demands and priorities and negotiate successfully