Senior Statistical Programmer Analyst – Contractor

🔥 5 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🖥 Software Engineer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Arcus Biosciences

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

Arcus Biosciences is a rapidly growing, clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines that may have the potential to help people with cancer live longer. Located in the San Francisco bay area, Arcus specializes in protein therapeutics, immuno-oncology, medicinal chemistry, and large molecule drug discovery. The company is focused on the discovery, development, and commercialization of novel combination therapies to treat cancer in areas of high unmet need, operating in a dynamic and team-driven environment.

📋 Description

• 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

• 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

• Equal employment opportunity and non-discrimination commitment • Remote work arrangement