Senior SAS Programmer - Clinical Trials & Data Validation

Lancesoft; Irvine (CA); Vor Ort; USD 115.000 - 155.000; Teilzeit

Zusammenfassung

Lancesoft is seeking a Senior Statistical Programmer Contractor to provide hands-on statistical programming support for clinical studies, including development and validation of analysis datasets and outputs, in line with regulatory and company standards.

The role requires independence, delivering high-quality programs, and collaboration with Biostatistics and Clinical Data Management, CRF reviews, SDTM/ADaM, and regulatory submissions.

Qualifikationen

• Bachelor's or Master’s in Statistics/Mathematics/Computer Science or related field with 8+ years of relevant statistical programming experience
• Experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device)

Aufgaben

• Develop complex analysis datasets, specifications, and summary outputs for clinical study reports, regulatory submissions, and internal presentations
• Create, modify, and maintain SAS programs to ensure efficient programming, reporting, review, and traceability
• Perform independent program review and validation with inspection-ready documentation
• Support ad hoc and planned analyses with the designated statistician
• Review CRFs, database specifications, edit checks, and data derivations with Clinical Data Management and Biostatistics
• Identify programming risks and communicate issues clearly to study team

Kenntnisse

SAS programming

Statistical programming

Regulatory knowledge

Cross-functional collaboration

Attention to detail

Ausbildung

Bachelor's or Master’s in Statistics/Math/CS

Tools

SAS Base

SAS/STAT

SAS Macros

CDISC (SDTM/ADaM)

Microsoft Excel/Word/PowerPoint

Jobbeschreibung

Lancesoft is seeking a Senior Statistical Programmer Contractor to provide hands-on statistical programming support for clinical studies, including development and validation of analysis datasets and outputs, in line with regulatory and company standards.

The role requires independence, delivering high-quality programs, and collaboration with Biostatistics and Clinical Data Management, CRF reviews, SDTM/ADaM, and regulatory submissions.