Arcus Biosciences - Hayward, CA
posted 11 days ago
Full-time - Senior
Hayward, CA
Professional, Scientific, and Technical Services
About the position
The Senior Statistical Programmer Analyst (Contractor, 1 year, full time) is responsible for ensuring the submission readiness of study data packages in accordance with CDISC standards and FDA guidance. This role involves hands-on programming, planning, execution, and quality assurance of statistical analyses and programming infrastructure. The position requires effective communication and collaboration with various stakeholders within the Biometrics team and beyond, focusing on immuno-oncology therapeutics in early development.
Responsibilities
- Develop specifications, build and execute programs for internal data reviews, publications, exploratory, post-hoc and regulatory review.
- Adopt a strategic approach to producing and prioritizing analytical deliverables, including 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.
- Demonstrate solid experience with CDASH and CDISC data standards (SDTM, ADaM) and health authority reporting requirements.
- Handle non-CRF data and work with diverse data types.
Requirements
- Bachelor's or Master's degree in a data science field (statistics, mathematics, epidemiology, computer science, bioinformatics, or equivalent experience).
- Minimum 8+ years programming experience in biotechnology or pharmaceutical clinical trial environment.
- Experience in software development and testing (e.g., SAS Macros tools, R functions/packages, Unix scripts).
- Expertise in developing applications using various technical stacks including 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 complex problems into clear programming code/tools.
- Basic project management skills and experience.
- Solid understanding of programming practices, relevant health authority guidelines (e.g., ICH-GCP, 21 CFR Part 11), and clinical R&D concepts.
- Demonstrated strong written and verbal communication skills.
Nice-to-haves
- Experience with health authority reporting requirements.
- Familiarity with programming practices and tools in a clinical trial environment.
Benefits
- Equal Opportunity Employer
- Commitment to diversity and inclusion in the workplace
