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
Report into Head of Statistical Programming
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
Adopts strategic approach to producing and prioritizing analytical deliverables which includes study level or integrated analysis for safety signal detection or 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 analyses results
Create/review SDTM/ADaM mapping specifications
Generate or validate SDTM domains, ADaM datasets, reviewer's guide, and define.xml files
Generate or validate TFLs to support the statistical analysis of data for clinical studies, regulatory submissions, and publications such as CSR, DSUR, IB, publications, etc.

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

Arcus Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind
Arcus is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status

Senior Statistical Programmer Analyst – Contractor

Key skills