Senior Statistical Programmer

Redbock - an NES Fircroft company; United States; Vor Ort; USD 140.000 - 170.000; Vollzeit

Zusammenfassung

Redbock - an NES Fircroft company in the United States seeks an experienced Statistical Programmer to support SAS scripting for Analysis Files, Tables, listings and figures in clinical trials. The role includes hands-on programming, adherence to study standards, and ensuring timely, high-quality delivery.

With 10+ years in statistical programming for clinical data, you will contribute to regulatory submissions and QC activities, ensuring accurate results for internal and external audiences.

Qualifikationen

• MS, BS/BA degree or other suitable qualification with relevance to the field.
• 10+ years of statistical programming experience with clinical trial data using SAS software.

Aufgaben

• Provide Statistical Programming support for SAS scripts and outputs for Analysis Files, Tables, listings and figures in clinical trials.
• Ensure effective planning to meet quality and timely delivery of deliverables.
• Comply with project/study programming standards and specifications.
• Ensure accuracy of clinical trial results via biometrics QC of documents with clinical data.
• Provide programming support for Investigator Brochures, publications, and regulatory submissions.
• Hands-on programming of in-house deliverables and verification reviews of SSPS, documents and presentations.

Kenntnisse

SAS programming

Biostatistics

Quality control

Regulatory submissions

Planning & reporting

Ausbildung

MS/BS in a related field

Tools

SAS

Jobbeschreibung

• Recent small to midsized pharma/biotech experience required – no recent CRO experience)
• Long term experience at most roles (2+ years)

Responsibilities:

• Provide Statistical Programming support either in the form of production or verification of SAS scripts and outputs for Analysis Files, Tables, listings, Figures, and any other form of Clinical Trial in addition to writing analysis file specifications and other relevant documentation of deliverables and analysis methods.
• Ensure effective planning to meet quality and timely delivery of deliverables.
• Comply with project/study programming standards and specifications following internal guidelines.
• Ensure accuracy of clinical trial results for internal and external audiences (e.g., regulatory authorities, academic community, and healthcare providers) via biometrics QC of documents with clinical data.
• Programming support for relevant deliverables, such as Investigator Brochures, publications, US and ex-US regulatory submissions.
• Hands-on programming of in-house deliverables.
• Verification Review of Statistical Analysis Plans, documents, spreadsheets, slides for in-house presentations and external publications.

Required:

• MS, BS/BA degree or other suitable qualification with relevance to the field.
• 10+ years of statistical programming experience with clinical trial data using SAS software.