Senior Statistical Programmer

United, WV, US • Posted 1 hour ago • Updated 1 hour ago
Full Time
On-site
Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

  • Status Reports
  • SAS
  • R
  • Collaboration
  • Data Management
  • Data Engineering
  • Regulatory Compliance
  • XML
  • Documentation
  • Publications
  • Inspection
  • Statistics
  • Biostatistics
  • Computer Science
  • Mathematics
  • Life Sciences
  • Pharmaceutics
  • CDISC
  • SDTM
  • Management

Summary

Job Description

The Senior Statistical Programmer will independently lead programming activities for assigned clinical studies while maintaining hands-on involvement in programming, validation, and technical oversight. This role combines study-level ownership, strong knowledge of clinical study data, direct programming expertise, and oversight of internal and vendor-produced datasets, tables, listings, figures, and regulatory submission deliverables.
\\n

\\n
Responsibilities:
\\n
    \\n
  • Lead study-level statistical programming activities, including planning, prioritization, timeline management, risk identification, and status reporting.
  • \\n
  • Develop, program, and validate SDTM and ADaM datasets, tables, listings, and figures using SAS and, where appropriate, R.
  • \\n
  • Collaborate closely with Biostatistics, Data Management, Clinical Operations, and other cross-functional teams to clarify requirements and resolve data, programming, and specification issues.
  • \\n
  • Review internally and externally developed programs, datasets, outputs, and regulatory submission deliverables to ensure accuracy, traceability, consistency, and compliance with CDISC standards and regulatory expectations.
  • \\n
  • Provide oversight and technical review of vendor deliverables, including specifications, datasets, tables, listings, figures (TFLs), define.xml, annotated CRFs, reviewer guides, transport files, and validation documentation.
  • \\n
  • Support clinical study publications, regulatory submissions, health authority requests, and inspection-readiness activities.
  • \\n
  • Monitor programming deliverables, dependencies, timelines, and risks, escalating significant issues and developing solutions as needed.
  • \\n
  • Partner with cross-functional stakeholders and external vendors to ensure programming activities remain aligned with study requirements and project timelines.
  • \\n
\\n

\\n
Qualifications:
\\n
    \\n
  • Bachelor's degree in Statistics, Biostatistics, Computer Science, Mathematics, Life Sciences, or a related quantitative discipline.
  • \\n
  • Minimum of 8+ years statistical programming experience in Biotech, Pharma, or CRO industry.
  • \\n
  • Strong knowledge of CDISC standards, including SDTM and ADaM.
  • \\n
  • Experience overseeing vendor deliverables and supporting regulatory submissions.
  • \\n
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: orcfeed
  • Position Id: 24495_29249_6fcde5a60404bc6c
  • Posted 1 hour ago
Create job alert
Set job alertNever miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

West Virginia

•

Today

Full-time

Remote or New Jersey

•

Today

Full-time

USD 133,000.00 - 173,000.00 per year

Remote

•

Today

Full-time

USD 177,000.00 - 308,000.00 per year

Remote

•

Today

Easy Apply

Full-time, Third Party

Depends on Experience

Search all similar jobs