Arcus Biosciences

Senior Statistical Programmer Analyst, Contractor

Arcus Biosciences

contract

Posted on:

Location Type: Remote

Location: United States

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Job Level

Senior

Tech Stack

Google Cloud PlatformPythonUnix

About the role

  • Support submission readiness of study data packages per CDISC standards and FDA guidance
  • Plan, execute, and ensure quality of statistical analyses and programming infrastructure
  • Report to Head of Statistical Programming and communicate with biostatisticians, clinical data managers, and team members
  • Develop specifications and execute programs for data reviews, publications, exploratory analyses, post-hoc analyses, and regulatory review
  • Manage on-time and quality delivery of CRO-generated analyses results
  • Create/review SDTM/ADaM mapping specifications, generate/validate SDTM domains, ADaM datasets, reviewer's guide, and define.xml files
  • Generate/validate TFLs for statistical analysis of clinical data, regulatory submissions, and publications

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
  • Equal Employment Opportunity Employer
  • Prohibits discrimination and harassment of any kind
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
statistical analysisprogrammingSASRPythonUnix scriptsCDISCSDTMADaMdata review
Soft Skills
communicationproject managementproblem-solvingnegotiationtime managementteam collaborationattention to detailadaptabilityconflict resolutionanalytical thinking