Senior Statistical Programmer Analyst – Contractor

Arcus Biosciences

. Support submission readiness of study data packages per CDISC standards and FDA guidance .

Posted 10/3/2026contractRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in statistical programming and analysis within clinical trial environments, with a strong focus on CDISC standards and regulatory compliance. Proficient in developing and validating datasets and analytical deliverables to support clinical research and regulatory submissions.

Highest-signal resume keywords

Statistical ProgrammingCDISC StandardsSAS ProgrammingR ProgrammingProject Management

ATS Keywords

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Hard Skills

Statistical AnalysisData ReviewProgramming in SASProgramming in RProgramming in PythonSDTM MappingADaM DevelopmentTFL GenerationUnix ScriptingData Management

Soft Skills

Communication SkillsCollaborationPrioritizationNegotiationProblem Solving

Tools & Technologies

SAS MacrosR Functions/PackagesUnixClinical Data Management SystemsRegulatory Submission Tools

Industry Keywords

BiotechnologyPharmaceuticalsClinical TrialsICH-GCP21 CFR Part 11

Tech Stack

Tools & technologies

PythonUnix

About the role

Key responsibilities & impact

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

Requirements

What you’ll need

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

Benefits

Comp & perks

Equal employment opportunity and non-discrimination commitment
Remote work arrangement